Yourlawyer.com (Alaris Infusion Pumps News)

Alaris Pump Recall Update

Tue, 04 Aug 2009 00:00:00 -0700

CareFusion Corporation, which is expected to become a public company following its planned spin-off from Cardinal Health, just issued an update to its previously disclosed recall of the Alaris System, said the U.S. Food and Drug Administration (FDA).

On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device's pumping mechanism. This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris® System. According the FDA, the potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.

Serial numbers of affected devices, CareFusion's short-term instructions to customers, and the firm's strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/. Also, following the FDA's 510(k) clearance of the firm's software correction in July 2009, CareFusion is now implementing corrections for units in the field.

CareFusion also began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. That update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.

In the interim, the FDA said customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates. CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company's Web site, and set up a dedicated call center for customer support, said the FDA. The June 12 letter can be accessed (in PDF format) at: http://www.legacycarefusion.com/alaris/brochure/Customer%20Letter%20-%20Signed.pdf

The FDA is also asking that any adverse reactions experienced with the use of this product, and/or any quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; or online at www.fda.gov/medwatch.

Customer inquiries should be addressed to the CareFusion recall center, tool-free, at 1-888-562-6018.

Alaris Pump Modules Recalled by Cardinal Health Following Death Reports

Thu, 27 Dec 2007 00:00:00 -0800

Alaris Pump modules manufactured by Cardinal Health where recalled this week due to a defect in the pumps that could lead to over-infusion. The company became aware of the defective medical devices following a review of customer complaints and service data. Cardinal Health received one report of an injury and two reports of patient deaths that may be associated with the defective Alaris Pump modules.

The Alaris Pump module recall involves model 8100—formerly known as Medley Pump module—shipped prior to September 27th. Cardinal notified customers by registered letter, posted the letter on their Web site, and set up a dedicated call center and the Food and Drug Administration (FDA) has been advised of the faulty Alaris Pump module.

This week’s announcement was an updated to Cardinal Health’s worldwide voluntary recall for its Alaris Pump module. The item is being recalled as the units may contain misassembled occluder springs which are bent, broken, nested, or missing. These defects in the Alaris Pump module occurred due to incorrect assembly during the manufacturing process. Misassembled springs could lead to over infusion that could result in serious adverse health consequences or death; over infusion may be difficult to detect because the misassembled springs can work intermittently and there is no warning or notification of an over infusion. The Alaris Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration such intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces.

Customer inquiries related to this action should be addressed to Cardinal Health's customer service center at 1-800-625-6627. Cardinal representatives are available at the center 24 hours a day, seven days a week. Cardinal Health says it will work with customers to minimize disruption while completing an inspection of the devices as quickly as possible at the company's service facility and repairing those units with misassembled springs. This includes dispatching field teams to customer sites and using a loaner pool of temporary substitute Alaris pump modules with hospitals while their pumps are being inspected at Cardinal Health's facility. Any devices found with misassembled springs will be repaired and then returned to the customer, along with their other devices that have passed inspection. In the interim, the company has developed an occluder pressure test to provide customers a method to potentially identify affected devices prior to Cardinal Health's inspection. The occluder pressure test may not be effective in detecting all misassembled occluder springs and a further inspection by the company is required.

The voluntary recall covers Alaris Pump modules distributed to 46 states, the District of Columbia, Canada, Guam, Puerto Rico, and Saudi Arabia. There have been approximately 201,000 Alaris® Pump modules distributed worldwide affected by this recall. All units shipped after September 27th have undergone a new inspection process to confirm correct assembly of the occluder springs and, therefore, the company has not included these units as part of this recall. Cardinal is working on product improvements to minimize future assembly problems.

Class 1 Recall: Cardinal Health Alaris SE Infusion Pumps

Tue, 26 Sep 2006 00:00:00 -0700

Date Recall Initiated: August 10, 2006

Product: Alaris SE Infusion Pumps (formerly Signature Edition ® Infusion Pumps) model numbers 7000, 7100, 7107, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232.

Use: These electronic infusion pumps are used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.

Recalling Firm:
Cardinal Health
10221 Wateridge Cir
San Diego , CA 92121
858-458-7000

Reason for Recall: Some Alaris SE infusion pumps have a design defect that can cause over-infusion of medications into a patient’s bloodstream. The touch-sensitive keypad used to program the pump sometimes registers a number twice when it has been pressed only once (“key bounce”). Thus the pump would deliver more than the intended amount of medication, leading to over-infusion. Over-infusion can potentially result in serious harm or death to the patient.

Public Contact:
Cardinal Health
10221 Wateridge Cir
San Diego , CA 92121

Alaris SE Call Center: (877) 552-4922

FDA District: San Diego

Advice to Users

FDA believes that the Alaris Signature Edition infusion pumps can be used safely by following these instructions provided by the company:

    Proper Stance
    When programming pumps, stand squarely in front of the keypad (ideally with the pump at eye level for best visibility) to facilitate proper depth of depressing each key.

    Listen
    Focus on listening to the number of beeps while programming IV pumps; each beep will correspond to a single digit entry. Unexpected double tone could indicate an unintended entry.

    Verify Screen Display
    When programming the pump or changing settings, always compare the patient's prescribed therapy or the medication administration record, original order, or bar code device to the displayed pump settings for verification before starting or re-starting the infusion.

    Independent Double Check
    Request an independent double check of pump settings by another practitioner before starting or changing infusions with hospital-selected high alert drugs.

    Look
    Before leaving the patient's room, observe the IV tubing drip chamber to see if the observed rate of infusion looks faster or slower than expected. Adjust accordingly.

For more information about using these pumps safely, see Cardinal Health’s Alaris SE Pump Recall Information. Also see Safety Information about the Alaris Signature Edition Gold Infusion Pump Seizure on the FDA Website.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Alaris Infusion Pump Defect Injury Lawyer

Tue, 26 Sep 2006 00:00:00 -0700

Alaris Infusion Pumps

On Monday August 28, 2006, Cardinal Health Inc. proclaimed they were suspending the manufacturing, sales, and installations of their Alaris SE infusion pumps. This action was taken after U.S. regulators seized approximately 1,300 of the devices on August 25, 2006. U.S. marshals seized the products from Alaris' manufacturing facility in San Diego, California at the request of the FDA. The FDA said in a statement that the pumps might pose a potential risk towards patients.

Cardinal stated that a sensitive keypad on the systems posed a chance of overdose of the IV drugs. Infusion pumps are electronic devices used to manage the release of intravenous solutions or medications. Cardinal Health Inc. said it is presently testing a modification of the devices that would diminish the sensitivity of the keypad. The new modification would need to be approved by the FDA.

According to the FDA the keypads on the Alaris pumps are prone to key bounce, which takes place when a number pressed on the pump records twice, although the operator only pressed the key once. If key bounce does take place and is not identified during programming verification, it can result in an infusion rate of at least 10 times the intended rate, the agency said.

The Food & Drug Administration stated their inspectors reveled that Cardinal Health Inc. unsuccessful followed the agency's manufacturing regulations for medical devices. The FDA said Alaris had been issued warning letters in August 1998 and October 1999 outlining the violations and was given chances to fix the violations, but failed to take proper actions.

The suspended pumps are Cardinal's Alaris Signature Edition Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231.

If you or a loved one suffered injuries from a Alaris Infusion Pump, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.