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.
Legal Help For Victims Affected By Baxter Infusion Pumps
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 or call us at 1-800-YOURLAWYER (1-800-968-7529).