Yourlawyer.com (Baxter Infusion Pumps News)

Baxter Heparin Vials Recalled Following Reports of 'Allergy-Type' Reactions

Mon, 21 Jan 2008 00:00:00 -0800

Heparin Sodium Injection Vials manufactured by Baxter HealthCare have been recalled because of a marked increase in adverse reactions related to the Heparin. Baxter has received 100 reports of allergy-type reactions linked to the Heparin, and one death at a Florida hospital could be linked to the Baxter Heparin recall.

According to the Baxter Heparin recall notice, a variety of reactions have been reported in relation to the recalled Heparin, including abdominal pain, abdominal pain (upper), decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, lacrimation increased, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, paresthesia (oral), pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli.

Involved in the Baxter Heparin recall are nine lots of Heparin Sodium 1000 unit/mL for injection.   They include:

•   NDC# 0641244045, Lot #107054 , Heparin 1000units/mL 1OmLvial, expiration date 10/2009
•   NDC# 0641244045, Lot# 117085, Heparin 1000units/mL 1OmLvial, expiration date 11/2009;
•   NDC# 0641245045, Lot# 047056, Heparin 1OOOunits/mL30mL vial, expiration date 10/2008
•   NDC#0641245045, Lot# 097081, Heparin 1OOOunits/mL30mL vial, expiration date 09/2009
•   NDC#0641245045, Lot# 107024, Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•   NDC# 0641245045, Lot# 107064 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•   NDC# 0641245045, Lot# 107066 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•   NDC# 0641245045, Lot# 107074 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009
•   NDC# 0641245045, Lot # 107111 Heparin 1OOOunits/mL30mL vial, expiration date 10/2009

This is not the first time that Baxter’s Heparin vials have caused problems. The Food & Drug Administration (FDA), in collaboration with Baxter, issued a two-page safety alert in February 2007 warning of the fatal dangers of mistaking high 10,000 unit and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors do not occur. The 2007 alert was issued after three infants died in Indiana after they were mistakenly given adult doses. In December, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin because of a vial mix up. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001.

According to the Baxter recall notice, no deaths have been reported in connection with the recalled Heparin vials. However, on Friday, a Florida TV station reported that one patient had died, and four others had suffered reactions that could be linked to the recalled Baxter Heparin. An official at HealthPark Medical Center in Lee County Florida told nbc2.com that they had removed all of the Baxter Heparin from the facility. State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility this week to see if the patient’s death and the other reactions were linked to the recalled Heparin.

Baxter COLLEAGUE Infusion Pumps Malfunction Yet Again

Wed, 24 Oct 2007 00:00:00 -0700

Baxter COLLEAGUE infusion pumps have been malfunctioning again under certain conditions, prompting new warnings from the company.   According to a letter sent to its Canadian customers, Baxter has received reports of incidents where the COLLEAGUE triple channel infusion pumps stopped infusing.   According to the “Urgent Device Correction” notice issued by Baxter, the company is working on a software solution to fix the problem with its COLLEAGUE triple channel infusion pumps.

The Baxter infusion pumps affected by the correction notice include Baxter COLLEAGUE triple channel Mono, CX and CXE Volumetric infusion pumps with product codes of 2M8153, 2M8163, 2M9163, DNM8153 and DNM9183. According to the correction notice, Baxter has received reports from 3 Canadian customers of at least six instances where defective COLLEAGUE infusion pumps stopped infusing.   In each instance, the pump issued an audible and visual alarm and displayed the error code 16:310:867:0002 before it stopped.   Baxter said that this malfunction of the COLLEAGUE infusion pumps occurred when the capacity of the buffer memory device was exceeded. While no injuries have been reported in relation to the defective Baxter COLLEAGUE infusion pumps, the company said that lab tests of the pumps showed that this malfunction had a high probability of occurring under certain circumstances.

While it works to correct the problem, Baxter has advised customers to utilize only two of the three channels on these defective COLLEAGUE infusion pumps, and to use a single channel device in place of the third channel. Customers should also have a back up single channel device on hand when therapy with the COLLEAGUE infusion pump includes all three channels infusing, and both the dose mode and flow check are enabled.   Also, Baxter warned that the dose mode feature on the COLLEAGUE triple channel infusion pump should not be used if it has not been previously enabled.

COLLEAGUE infusion pumps have long been a problematic device for Baxter. In February 2005, Baxter recalled COLLEAGUE infusion pumps because they had a tendency to shut down unexpectedly, thus interrupting the flow of life-sustaining fluids and medications. Prior to the 2005 recall, Baxter had received reports of six injuries and three deaths linked to the malfunctioning infusion pumps. The US Food and Drug Administration (FDA) deemed the 2005 action a Class I recall because the pumps had the potential to cause serious injury and possibly death when used. During that recall, the FDA seized 7,000 of the devices from Baxter’s Illinois headquarters. In October 2005, the agency cleared a modified version of the COLLEAGUE pump for marketing.

Over the summer, Baxter issued yet another Class I recall for nearly 1,500 COLLEAGUE and Flo-Gard infusion pumps after routine quality control inspections revealed that the infusion pumps could have been returned to customers without ever having been repaired. During those inspections, Baxter found that repair, testing and inspection data sheets for the infusion pumps had been falsified. At that time, Baxter said that it had dismissed three employees implicated in the fraud.

FDA Announces Class 1 Recall Baxter Infusion Pumps

Mon, 06 Feb 2006 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) and Baxter Healthcare Corporation have notified healthcare professionals regarding the class 1 recall of all models of Colleague and Colleague CX volumetric infusion pumps.

The electronic devices are subject to multiple malfunctions that can delay or interrupt therapy, resulting in potentially life-threatening situations for patients receiving critical medications and fluids, according to an alert sent Friday from MedWatch, the FDA's safety information and adverse event reporting program.

The action follows 2 previous recall notices in July and September 2005, and an urgent device correction notice issued to consumers in December, alerting them to additional problems with the pumps. These included battery undercharging, false air-detection alarms, gearbox wear, underinfusion, and non-detection of upstream occlusion.

The FDA has determined that the pump's battery charge level indicator may overstate the battery power level and shut down during battery-powered operation if not charged for a full 12 hours following a “low battery” alarm.

In addition, pump sensors may misinterpret a stretch or pull of the tubing as air in the line, resulting in a false alarm and device shut-down. Shut-down may also be caused by worn parts in the motor.

Obstructions during tube loading can cause the upper jaw of the pump head to move out of alignment, resulting in insufficient fluid delivery.

Improperly spiked bags, use of a source container that has had all air removed, improper venting of the container, and an unopened air vent above the burette chamber can result in failure to detect upstream occlusions.

According to an FDA news release, the company has acknowledged the agency’s assessment of corporate-wide quality system and device reporting deficiencies and confirmed its commitment to resolving all issues according to an aggressive timeline.

The infusion pumps are used for the controlled delivery of medications or other fluids to patients through intravenous, intraarterial, epidural, or other direct line into the bloodstream.

Affected devices include models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.

Further information regarding the recall may be obtained online at http://www.baxter.com or by contacting Baxter Healthcare at 1-800-422-9837. Answers to technical questions are available at 1-800-THE-PUMP (800-843-7867).

Healthcare professionals are encouraged to report adverse events related to use of the volumetric infusion pumps to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Health Canada Endorsed Important Safety Information on the Market Removal of Baxter/Sabratek 6060 Infusion Pumps

Mon, 21 Nov 2005 00:00:00 -0800

Re: Market Removal of Baxter/Sabratek 6060 Infusion Pumps

Dear Director of Nursing:

Baxter Corporation is sending this communication to provide you with important safety information concerning the 6060 Infusion Pump. Baxter has received reports of failures within the PCA profile as well as reports of incidents that result in interruptions of therapy in various profiles. Details are outlined in the Reported Problems sections below. Due to the technological limitations of this product and the obsolescence of certain critical components, Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion Pumps from the market. As the timing of this removal will depend upon your ability to evaluate and implement a substitute device, Baxter will coordinate with customers individually to ensure a smooth transition. We will continue to produce sets and provide service during the transition period.

During this period of product removal Baxter is advising you to:

* Discontinue the use of the PCA profile to avoid a potential overinfusion or non-delivery condition. While the probability of occurrence of the PCA profile delivery failures is rare, patients should be converted to another delivery profile or device.

* Immediately discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm.

Failure to follow the above instructions could result in an unsafe situation for the patient.

To help explain all of the current instructions relative to this and previous field corrective actions, a chart of the pump’s profiles and the associated instructions is included with this notification as Attachment 1. This attachment should be distributed to all users of the pump.
Reported Problems:

PCA Profile Delivery: The PCA mode should not be used, and should be disabled on all 6060 Infusion Pumps.

* Event Log Discrepancies: Baxter has received one death and two serious injuries reports that may be associated with potential over infusions within the PCA profile. In each case, the event histories indicated that the device failed to return to the basal rate following a bolus request, but also indicated that the bolus volume was not delivered. Despite exhaustive internal and external investigations, Baxter has been unable to replicate these types of failures.

* Unrequested Bolus Dose: Baxter has identified that a frayed PCA cord or fluid ingress into the device may create an intermittent short of the PCA circuit and simulate the repeated pressing of the PCA button. As a result, bolus doses may be delivered (within the programmed prescription limits) without the patient initiating the request.

* Undelivered PCA Bolus Requests: Baxter has received reports where the pump will not deliver requested PCA boluses while in the TOTAL MEDS ALLOWED mode.

Interruption of Therapy

* Non-Delivery Without Indication: Baxter has received reports where the infusion unexpectedly stops without an alarm or malfunction code. This has been observed in the Auto-Ramp and 25-Period profiles.

* Unwarranted Alarms: Baxter’s investigation into the occurrence of some malfunction alarms has identified that the pump may incorrectly generate an alarm condition even if an error is not present. The most commonly seen malfunction alarms include Malfunction 7, 9, 20, 25, and 26 codes.

Product Removal

Baxter will be working with customers over the next twelve (12) months to conduct a controlled removal of all 6060 Infusion Pumps from the market. However, due to the quantity of pumps in the field, we recognize it may take customers time to safely replace their existing 6060 pumps with alternatives. During this transition period, Baxter will continue to provide service and sets for the 6060 pump. Your Baxter Sales Representative will contact your facility within the next week to discuss alternatives and help coordinate the return of the 6060 pumps to Baxter.

Please complete the attached reply form confirming your receipt of this letter and fax it back to Baxter at the number provided on the form. Returning the form promptly will prevent you from receiving a repeat notice. If you provide 6060 pumps to other services or facilities, please forward this information. It is imperative that all end users of the 6060 pumps be notified.

We apologize for any inconvenience this may cause you and your staff. We are committed to helping you work safely through this difficult situation. If you have questions regarding this communication, please call The Center for One Baxter at 1-800-422-9837.

Health Canada has been notified of this action.

Baxter Healthcare Corp Withdraws Infusion Pump From Market

Wed, 16 Nov 2005 00:00:00 -0800

Baxter Healthcare announced Tuesday that it plans to voluntarily withdraw its 6060 Multi-Therapy Infusion Pump from the market over the next 12 months.

This pump delivers intravenous medications to patients who are primarily in alternate care settings or at home. There are approximately 34,000 pumps currently in use worldwide, including 30,000 in the United States.

In a letter to customers, Baxter stated that it had received reports of one death and two serious injuries due to malfunctions in the pump. The pump may deliver drugs when they are not requested or fail to deliver drugs when they are requested. These product failures can result in an unsafe situation for patients.

Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion pumps from the market. During the transition period, Baxter will continue to provide service and sets for the 6060 pump. Baxter has entered into an agreement with Smiths Medical to provide alternative infusion pumps and products during the transition.

This is not the first time that Baxter has had a problem with its medical pumps. In September, there was a recall of the company’s Colleague Infusion pumps due to battery problems, and in October, the U.S. Food and Drug Administration (FDA) seized 6,000 pumps from Baxter’s manufacturing facilities in Illinois because the firm had continually failed to follow medical device manufacturing requirements.

FDA Hits Baxter on Pump Failures

Sat, 15 Oct 2005 00:00:00 -0700

Baxter International failed to properly inform U.S. regulators about problems with its medical infusion pumps, which have been linked to patient deaths, and the company violated manufacturing requirements, the Food and Drug Administration alleged Friday.

The agency, in a statement released Friday, also contended Deerfield-based Baxter failed to take appropriate actions to correct the violations.

The pumps are used to administer medicines and intravenous fluids to patients in hospitals and alternative care sites. Defects can cause the devices to unintentionally shut down.

"We're working diligently with the FDA to address all of their concerns," Baxter spokeswoman Cindy Resman said.

An FDA spokeswoman declined to provide information on possible penalties Baxter could face, noting the investigation is continuing.

On Thursday, Baxter said the agency had seized nearly 7,000 of its company-owned pumps, including 6,000 Colleague infusion pumps and 850 Syndeo syringe pumps that were on hold at company sites in Buffalo Grove and Waukegan.

The FDA said U.S. marshals seized 4,000 Syndeo and Colleague infusion pumps from Baxter's warehouse in Buffalo Grove and 135 Syndeo pumps from its distributor's warehouse in Waukegan.

Resman said Friday the nearly 3,000 remaining pumps are on hold at a company site.

No products were seized from health care facilities or individual users, and the FDA said there are no plans to do so. Health care facilities can continue to use pumps in their possession, guided by instructions Baxter previously provided them, the agency said, while adding that users should recognize the types of problems that could occur and have a backup plan.

Baxter is repairing the roughly 250,000 Colleague infusion pumps and 5,000 Syndeo infusion pumps in use worldwide.

Baxter halted shipments of the popular pumps in July after determining that flaws in the Colleague pumps might have resulted in three deaths and six serious injuries. The company took a $65 million charge in the second quarter because of its remediation actions.

Last month, Baxter said as many as seven deaths might be linked to the problem pumps, and the FDA categorized the voluntary notices sent out by the company to Colleague pump users early this year as "Class 1" recalls a serious designation, but one that doesn't require Baxter to pull the products from the market.

Baxter: FDA Seizes Recalled Drug Pumps

Thu, 13 Oct 2005 00:00:00 -0700

Baxter Healthcare Corp. said Thursday that the Food and Drug Administration seized infusion pumps the medical device maker held at two facilities in Illinois following a recent recall of the products.

The company said about 6,000 Colleague infusion pumps and 850 Syndeo syringe pumps were seized at the facilities. The devices, which deliver controlled amounts of intravenous drugs to patients, were recalled in September after battery problems were linked to four deaths and 10 serious injuries. The seized products had been put on hold by Baxter after the FDA classified the recall as a Class I -- the most serious type -- an action taken when defective products pose a life-threatening risk.

Baxter said it was unable to provide to customers with replacement pumps that have been removed from service. The company continues to work with the FDA on corrective actions concerning the devices. The recall does not affect pumps currently being serviced by Baxter.

About 250,000 Colleague pumps are in use worldwide, with more than 80 percent in the United States. Worldwide, there are about 5,000 Syndeo pumps in use.

Baxter's February 2005 Corrective Action for COLLEAGUE Infusion Pump Receives FDA Class I Designation

Wed, 21 Sep 2005 00:00:00 -0700

Baxter Healthcare Corporation announced that it was notified this week by the U.S. Food and Drug Administration (FDA) that the FDA has classified a February 25, 2005 voluntary notice from Baxter to customers regarding the company's COLLEAGUE Volumetric Infusion Pump as a Class I recall.

All COLLEAGUE infusion pump models are affected. This classification does not require the return of infusion pumps currently in the market. Baxter has advised health care institutions to have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

Specifically, there have been reports of damage to the pump's batteries, including swelling and excessive discharge. Both of these issues will result in irreversible damage to the battery. If either one of these situations occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of life-sustaining therapy and the possible death or serious injury of patients. To date, Baxter has received reports from customers of battery damage due to excessive discharge, which may have been associated with four deaths and ten serious injuries.

Normally, a properly maintained battery will provide approximately 30 minutes of remaining infusion time during a "battery low" alert. This is then followed by a "battery depleted" alarm that will stop the infusion of therapy and trigger an audible tone. However, for a pump with a damaged battery, the time frame between a "battery low" alert and a "battery depleted" alarm can be much shorter. It is also important to note that when the batteries become excessively discharged, the battery charge level indicator may overstate the amount of battery charge remaining.

In the Important Product Information Letter dated February 25, 2005, Baxter notified its users of the actions they can take to minimize the occurrence of these device failures, including following proper battery maintenance procedures. The company informed users that a modified battery harness could be installed in the pumps to help prevent the batteries from swelling. The letter also stated that future software updates would help address the issue of battery damage due to excessive discharge.

Earlier this year, Baxter announced that the company would voluntarily hold shipments of new pumps until issues are resolved. Baxter continues to address this issue as part of its remediation efforts previously communicated on July 21, 2005. The company does not expect any additional charges to cover costs associated with these issues.

Approximately 256,000 COLLEAGUE infusion pumps are currently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected.

Baxter Infusion Pump Lawsuit Lawyer Recall

Wed, 21 Sep 2005 00:00:00 -0700

Baxter Infusion Pumps

On November 15, 2005, Baxter International Inc. informed the FDA it was withdrawing the 6060 Multi-Therapy Infusion pump because of problems happening when the device is used to distribute pain and other critical medications. The pump delivers intravenous medications, commonly in home and non-hospital settings. The withdraw will take approximately 12 months to complete.

A Baxter spokeswoman said the company has received reports of one death and two injuries that may have been linked with the pump. About 34,000 of the 6060 Multi-Therapy Infusion pumps are in use globally, with an estimated 30,000 in the United States. Baxter said it alerted customers and the U.S. Food and Drug Administration about its action on the 6060 pump.

The company had projected 2005 worldwide sales of the 6060 pump and related disposable products of about $15 million.

Baxter Healthcare Corporation announced that it was informed by the U.S. Food and Drug Administration (FDA) that the FDA has classified a February 25, 2005 voluntary notice from Baxter to customers regarding the company's COLLEAGUE Volumetric Infusion Pump as a Class I recall. Baxter has advised health care institutions to have a backup pump available to mitigate any disruptions of infusions of life-sustaining drugs or fluids. There have been reports of damage to the pump's batteries, including swelling and excessive discharge.

Both of these issues will result in irreversible damage to the battery. If either one of these situations occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of life-sustaining therapy and the possible death or serious injury of patients. Baxter has received reports from customers of battery damage due to excessive discharge, which may have been associated with four deaths and ten serious injuries.

An estimated 256,000 COLLEAGUE infusion pumps are currently in use, including approximately 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

February 25, 2005 Recall
The FDA revealed that Baxter Healthcare Corporation initiated an international recall of all models of its Colleague Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected are: Models 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R. Approximately 255,000 Colleague Volumetric Infusion Pumps are presently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.

Based on information from a current FDA inspection and independent analysis of the failure modes by FDA's Office of Science and Engineering Laboratories, as well as an all-inclusive assessment of adverse event reports in FDA's database, FDA has determined that this action is a Class I recall. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product will cause serious injury or death.

Given the widespread use of these pumps and the multiple failure modes, FDA is quickly informing users of this important safety issue," said Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. "We will continue to monitor the situation closely and inform the public immediately of any new developments."

The firm notified customers today that it has voluntarily stopped shipping Colleague Volumetric Infusion Pumps until the problems are resolved. Baxter also advised customers on March 15, 2005, to stop using any pumps that exhibit a failure code beginning with 402, 403, 533, 535, or 599, related to these electronic problems. Additionally, Baxter advised customers to take out of service any pumps that exhibit failure codes 810:04 and 810:11 related to air-in-line sensor problems, until they are inspected by authorized service personnel.

Additionally, to the shut-down problem, the device may exhibit two additional failure modes: Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion. Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted.

Additionally, these failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to mitigate any disruptions of infusions of life-sustaining drugs or fluids.

April 2006 FDA Warning
On April 28, 2006, the FDA recommended that all healthcare providers take important safety steps when using the COLLEAGUE Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The COLLEAGUE pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for COLLEAGUE infusion pumps.

In addition to the recommendations made by Baxter Healthcare Corporation when using the COLLEAGUE Volumetric Infusion Pump, FDA is strongly recommending the following measures:

Do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, if possible.
Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available).
Monitor patients and check the pumps frequently.
Report any problems as soon as possible to Baxter and FDA.
Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on COLLEAGUE Pumps.
If your facility relies primarily or entirely on COLLEAGUE Pumps, you may wish to consider evaluating other options for infusion therapy.

The FDA is working continuously with Baxter to resolve problems with the COLLEAGUE pump as quickly as possible, mindful of concerns about the availability of replacement units. As a result, users should understand that at this point the FDA couldn’t guarantee that Baxter’s proposed corrections adequately address the problems encountered with these pumps. Baxter’s replacement units have not been cleared for marketing at this time, and will not be cleared until we are able to provide reasonable assurance that they will function reliably to meet user needs.

June 20, 2007 COLLEAGUE Volumetric Recall
On July 20, 2007, the FDA announced that on June 20, it had ordered a Class I recall of Baxter HealthCare Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps. The triple channel COLLEAGUE pumps involved in the recall were part of a remediation program initiated by Baxter to replace infusion pumps from the 2005 recall. The upgraded infusion pumps were recalled because of a software glitch that caused the pumps to alarm, display an error code (16:310:867:0002) and stop infusion. The recalled devices were used to deliver three intravenous fluids to a patient at one time.

Prior to the recall, Baxter had received reports of 16 serious injuries linked to the malfunctioning pumps in the US. The malfunctions occurred during user programming with all three channels infusing fluids at the same time. In all cases, the pump stopped the infusions in all three channels, which caused it to activate an audible and visual alarm. From May 14, 2007 through June 18, 2007, Baxter distributed 4,512 infusion pumps to 420 customers (distributors and medical facilities) within the U.S. and to 7 customers outside the U.S. Baxter requested that all of the affected triple channel pumps be immediately removed from service. These pumps were identified by two attached hangtags entitled “Battery” and “Power On.” Baxter informed their customers that representatives would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps.

June 21, 2007 COLLEAGUE and Flo-Gard Recall
On June 21, 2007, upon discovering that repair records at Baxter HealthCare’s Phoenix Service Center had been falsified, the FDA ordered a Class I recall for 534 COLLEAGUE and Flo-Gard infusion pumps that had been returned to the company for repair. Baxter said that there was a possibility that the pumps were returned to customers without having been repaired. The recall, which was announced by the FDA on July 27, covers COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGE CX Volumetric Infusion pump 2M8161 and 2M8163; and Flo-Gard Volumetric Infusion pump 2M8063 and 2M8064 distributed between From April, 2006 through February, 2007. During routine quality control inspections it was discovered that the pumps could have been returned to customers without ever having been repaired. During the inspection, Baxter found that repair, testing and inspection data sheets for the pumps had been falsified. Baxter said that it had dismissed three employees implicated in the infusion pump fraud.

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. Defects in the pumps could result in over or under infusion. The pumps could also fail to detect either occlusions or air in the intravenous line, and they run a risk of causing electrical shock. Other malfunctions could cause infusions of life-preserving fluids and medications to stop. The company requested their customers to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for repeat inspections and servicing. Baxter will provide loaner pumps to customers that require them, free of charge.

Baxter Infusion Pump Lawsuit Attorneys
If you or a loved one suffered injuries or death from a recalled Baxter COLLEAGUE or Flo Guard Volumetric infusion pump you have valuable legal rights. To see if you have a case for a Baxter infusion pump lawsuit please fill out the form at the right for a free case evaluation by a qualified defective Baxter infusion pump lawsuit attorney.