Baxter Forced to Recall Colleague Infusion PumpsMay 4, 2010 | Parker Waichman LLP
Baxter International has been ordered to recall its Colleague infusion pumps under an agreement with the U.S. Food & Drug Administration (FDA). According to the agency, Baxter Colleague infusion pumps have been associated with 56,000 complaints of injuries, deaths and malfunctions from 2005 to 2009.
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, other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.
According to an FDA press release, the Colleague Infusion Pump recall order is based on Baxter’s longstanding failure to correct many serious problems with the devices, including battery failures and software errors. The FDA believes there may be as many as 200,000 Colleague infusion pumps currently in use.
The FDA said it has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues. 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, the FDA said.
According to the FDA, Baxter last month submitted a proposed correction schedule to the agency that stated that the firm did not plan to begin the latest round of corrections to the defective pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. The FDA deemed this plan unacceptable, and ordered the recall in accordance with the 2006 consent decree.
As a result, the FDA is now ordering Baxter to:
• Recall and destroy all Colleague infusion pumps.
• Reimburse customers for the value of the recalled device
• Assist in finding a replacement for these customers.
Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition, the FDA said.
According to a New York Times report, the Colleague infusion pumps have not been sold to new customers since 2005 and will be phased out. The company expects to offer to exchange its Sigma Spectrum infusion pumps for the Colleague pumps.