Recalls

FDA cites Baxter for failure to correct defects in infusion pumps

Baxter Healthcare Corp., has been ordered by the Food and Drug Administration (FDA) to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States because of longstanding failure on Baxter’s part to correct many serious problems with the pumps. The FDA believes as many as 200,000 of the pumps are currently in use. Baxter is required to provide refunds and find acceptable replacement products at no cost to its customers.

The infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. They are widely used in hospitals or other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

The FDA has been working with Baxter since 1999 to correct numerous flaws in the devices. Since then, the pumps have fallen under several Class 1 recalls for battery swelling, inadvertent power off, service data errors, and other issues. A Class 1 recall is the most serious type of recall the agency can issue and is placed on products that pose a significant risk of serious injury or death.

In June 2006, the FDA obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction. In April 2010, Baxter submitted a proposed correction schedule that stated it did not plan to begin the latest round of corrections until May 2012 and that completion of the proposed corrections would not be made until 2013. Based on that information, with the understanding that the defective devices would remain in use until 2013, the FDA determined that ordering Baxter to recall and destroy the devices was necessary.

In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address specific safety concerns.

Any adverse events or quality issues with this or any other device should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.