200,000 Pumps Used in Hospitals Recalled – 5 Years after Defects Discovered

By May 19, 2010News

Baxter International Inc., a manufacturer and marketer of medical products, has been ordered to recall and destroy 200,000 of its Colleague brand pumps by the U.S. Food and Drug Administration (FDA). Baxters Colleague brand pump is a type of infusion pump found in hospitals. Infusion pumps are used to automatically deliver medicine, fluids, and nutrients into a patients system. The defective pumps either delayed or interrupted the infusions. Baxter ceased selling the pump in 2005 due to problems with design flaws, battery failures, and software errors, but the previously sold pumps remained in use. Since then there have been 56,000 reports of malfunctioning infusion pumps of all brands resulting in over 500 deaths and an untold numbers of injuries. Baxter wanted to leave its remaining pumps on the market until 2013 but the FDA rejected this plan citing the persistent safety problems. Baxters chairman and CEO Bob Parkinson told his companys shareholders that the situation languished far beyond what it should have. While Parkinsons admission is warranted, the question should be why the pumps weren’t taken off the market earlier. According to the FDAs news release, Baxter was working with the FDA to try to correct the defects since 1999. Partial recalls were intermittently issued. Yet, the pumps werent completely recalled until over 10 years later. Prompted by the Baxter recall, Baxter’s comptetitor Hospira voluntarily ceased sales of one of its infusion pump brands as well, raising questions of the extent of infusion pump safety issues.