According to the United States Food & Drug Administration (FDA), on April 23, 2010, Baxter International’s Colleague infusion pumps were linked to over 56,000 complaints of injuries, deaths, and malfunctions from 2005 to 2009. The Baxter Healthcare Corporation is Baxter International’s primary U.S. subsidiary. The Colleague infusion pump is used to administer drugs and liquids to patients. Indeed, these infusion pumps are primarily used by hospitals to deliver nutrients to patients in comas, deliver blood-thinning drugs to hear patients, and chemotherapy to cancer patients. According to Baxter spokesperson, Erin Gardiner, while the Colleague infusion pump is being phased out and has not been sold to any new customers since 2005, there are just under 200,000 of these pumps still in use by patients.
According to federal regulators, Baxter International is recalling its Colleague infusion pumps from the American market pursuant to an agreement with the FDA. This agreement is aimed at fixing the reported problems with battery failures and software errors. Despite all the complaints and the reported problems with the Colleague infusion pump, Baxter proposed to keep the Colleague infusion pumps in use until 2013; however, on April 30, 2010, the FDA rejected that proposal as unacceptable and ordered the massive recall. Baxter is now stating that it expects to offer to exchange the Colleague pumps for the Sigma Spectrum infusion pumps.
It is certainly alarming that there have been over 56,000 reported complaints regarding the pumps’ malfunction. It is also shocking that Baxter wanted to continue the use of the Colleague infusion pumps despite all the complaints, injuries and deaths. Perhaps what is most concerning is that these pumps are still being used by approximately 200,000 patients. If you, a loved one, or a friend has an infusion pump, it is incumbent that you let them know about this massive recall and determine what type of infusion pump is being used. Given that these pumps are administering medications to patients, a battery error or software malfunction could be deadly.