5.04.2010

Baxter told to recall and destroy hospital IV pumps

The LA Times is reporting that medical manufacturing giant Baxter is being forced to "recall and destroy" Hospital IV pumps that we use at our hospital and at hospital across the nation. The pumps in question are known as Colleague Guardian pumps and the move is part of a larger effort by the FDA to crack down on IV pump safety issues.
The change comes after 710 deaths associated with malfunctioning infusion pumps used in homes and hospitals during the last five years, according to American Medical News. The agency has received 56,000 adverse-event reports regarding the devices during that time period and issued 87 recalls -- 14 of those in the FDA's highest-risk class I category. 
"There have been problems with every kind of infusion pump on the market, across the entire industry," said Jeffrey Shuren, MD, director of the agency's Center for Devices and Radiological Health. The initiative "represents a major shift in FDA's approach to medical device safety," Dr. Shuren said. "Instead of responding to problems one by one and manufacturer by manufacturer, we are taking comprehensive steps to prevent problems by fostering the development of safer, more effective infusion pumps industrywide."

The FDA said Baxter must "recall and destroy" all of its Colleague pumps, saying the action was based on "a long-standing failure" of the company to correct serious problems with them, the LA Times reported. Baxter issued a corrective action plan, however the FDA found it wanting, responding with the order for recall.


As the LA Times reported:
The agency called the plan "unacceptable" and said it would have allowed the company to keep a device with "known safety concerns" on the market until 2013. The FDA said it was not satisfied with Baxter's timetable for fixing Colleague, a pump the company stopped selling in 2005 because of various design flaws, battery failures and related software issues.
"The FDA has been working with Baxter since 1999 to correct numerous device flaws," the agency said in a statement. "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."

Based on a consent decree with FDA, Baxter hasn't sold the pumps directly since 2006, but they still remain on the market. 

Baxter is offering to exchange it's new Sigma smart pumps for the recalled pumps without charge. 

Personally I like Hospira's plum pumps, but I doubt we'd be able to get a hospital's worth for free ....

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