More Infusion Pump Woes for Baxter; FDA Order Recall In a move reflective of its quest for greate

More Infusion Pump Woes for Baxter; FDA Order Recall

In a move reflective of its quest for greater infusion pump safety, the U.S. Food and Drug Administration (FDA) has ordered Baxter International Inc. to recall and destroy all Colleague brand pumps currently on the market. The command, according an FDA news release, is based on a “longstanding failure to correct many serious problems with the pumps.”

Agency officials estimate the recall could affect as many as 200,000 Colleague Volumetric Infusion Pumps, a device that Baxter stopped selling in 2005 due to various design flaws and software issues. The pumps have been the subject of several Class I recalls for battery swelling, inadvertent power shutdowns and service data errors.

Baxter executives estimate the recall could cost the company up to $600 million. Officials have pledged to work with the FDA to minimize the disruption in service to hospitals and other health care facilities that still use the Colleague pumps. Affected customers, according to the company, could be entitled to a refund or an exchange (at no charge) for Baxter’s Sigma Spectrum infusion pumps.

“The situation has languished far beyond what it should have,” Bob Parkinson, Baxter’s chairman and CEO, told shareholders during the company’s annual meeting earlier in May. He said the type of design improvements requested by the FDA were “close to impossible” to achieve without “fundamentally redesigning” the Colleague pump.

Baxter has been operating under a 2006 consent decree with the FDA that allowed the agency to recall the pumps. Though they remain on the U.S. market, the Deerfield, Ill.-based firm has not sold or distributed them in five years. During its last full year on the market, the device generated $170 million in sales for Baxter.

An avalanche of documented reports of safety problems with infusion pumps over the last decade or so prompted the FDA to launch a new initiative late last month to address pump safety. Part of the initiative requires manufacturers to perform more testing on the devices before they can be sold to customers. Infusion pumps 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.”

“Infusion pumps … have been the source of persistent safety problems,” according to the agency. Just how persistent is astounding: In the last five years, the agency received more than 56,000 reports of adverse events associated with the use of infusion pumps, with 500 of those events resulting in deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address safety concerns, FDA data show.

“An FDA analysis of these adverse events has uncovered software defects, user interface problems and mechanical and electrical failures,” according to a statement from the FDA statement. “Problems with infusion pumps are not confined to one manufacturer or one type of device.”

Jeffrey Shuren, M.D., head of the FDA’s Center for Devices and Radiological Health said many of the problems with the pumps seem to be related to “deficiencies in device design and engineering” more often than user error.