Baxter Details Infusion Pump Recall Plan
Baxter Healthcare Corporation has released details of its infusion pump recall plan. Baxter was ordered by the FDA to issue a recall and refund of its Colleague Volumetric Infusion Pumps (CVIP). This was after several years of malfunctions and defective parts were reported. Baxter had been working with the FDA since 1999 to fix the problems in the infusion pump, but was unable to bring the pump into regulation of the law.
Some of the flaws include battery failures, inadvertent powering off and service data errors. Infusion pumps are medical devices that deliver liquids into the body, including medication or nutrients, in a controlled way. This is increasingly being used in the home as well as in hospital settings, particularly for those with chronic pain issues and cancer.
The plan is to recall as many of the 200,000 CVIP devices currently in use in the United States as possible. Under FDA rules, Baxter also has to provide a transition guide for recalling the infusion pumps. This guide will include alternative pump suggestions, guidelines to minimize patient risk during the transition period and information on the refund, replacement, and lease termination programs.
Baxter will continue to service these devices, up to 24 months, if provided a completed Certificate of Medical Necessity produced by Baxter. This form requires information including the number of the CVIP in use, serial numbers and date that the CVIP is expected to be removed. Baxter will finish the recall program of its infusion pumps by July 14, 2012.
Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, has said “Baxter’s Colleague infusion pumps are commonly found in many hospitals and facilities. Considering the size of the recall the FDA reached out directly to the hospital community in order to determine what would be fit their needs in a transition plan.” Prior attempts to correct this problem included an injunction in which Baxter was to stop manufacturing and distributing all models of the infusion pump and in April 2010, Baxter’s correction schedule for the CVIP was rejected by the FDA and the recall was issued with the authority from the 2006 injunction.
Dr. Shuren has said, “This action reflects the agency’s commitment to protect patients by removing unsafe infusion pumps and to promote public health through assuring the availability of safe and effective alternatives.” Patients are encouraged to contact their doctor for details of a transition plan.