The FDA is ordering Baxter Healthcare Corp. to recall and destroy all of its Colleague Volumetric Infusion Pumps. The agency said in a May 3 news release(www.fda.gov) that the action is based on the manufacturer's "longstanding failure" to correct serious problems with the product.
In addition to the recall, the FDA is ordering Baxter to reimburse customers for the value of the recalled pumps and to assist them in finding replacement devices. The agency estimated there are as many as 200,000 Colleague pumps currently in use in U.S. hospitals, other clinical settings and homes.
According to a May 3 Baxter press release(www.baxter.com), the company said it will record a pretax special charge of $400 million to $600 million in the first quarter to cover the estimated cost of the recall.
Baxter said details of the recall and the reimbursement process were not yet finalized. The manufacturer said details will be posted on its website when they become available.
Infusion pumps deliver fluids -- including nutrients and medications -- into a patient’s body in a controlled manner. However, Colleague pumps have been the subject of Class I recalls -- the FDA's most severe recall status, signifying there is a potential for serious injury or death associated with a product -- for battery swelling, inadvertent power loss, service data errors and other issues.
The FDA has been working with Baxter since 1999 to correct these problems. In 2006, the agency obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until it corrected manufacturing flaws and until devices already in use were fixed.
FDA officials said Baxter made numerous changes to the pumps but has not yet solved the problems. On April 8, Baxter submitted a proposed correction schedule to the agency that called for the manufacturer to begin another round of corrections in 2012 with completion expected in 2013.
The FDA found this proposal and timeframe unacceptable and ordered the recall.
Baxter and its Colleague product are not the only manufacturer or brand of infusion pumps under scrutiny. The FDA said that in past five years, it has received more than 56,000 reports of adverse events associated with the devices, including serious injuries and more than 500 deaths caused by software defects, user interface problems and mechanical and electrical failures.
Between 2005 and 2009, 87 infusion pump recalls were mandated because of safety concerns, the agency said.
Last month, the FDA announced a new initiative(www.fda.gov) to address safety problems associated with infusion pumps. The agency said it plans to establish new premarketing requirements for manufacturers.