The U.S. Food and Drug Administration today said Baxter International Inc. needs to take several steps designed to follow through on a recall of its Colleague infusion pumps including providing customers with a “a refund, a replacement pump, or lease termination.”
In April, the FDA ordered Baxter to recall about 200,000 Colleague brand infusion pumps, which are mainly used in hospitals to deliver medicine and other fluids to patients. The agency also said Baxter must destroy all of its Colleague pumps, adding that the action is based on “a longstanding failure” of the company to correct serious problems with the device.
The Deerfield-based medical product giant incurred a pretax charge of more than $400 million in the first quarter to cover the cost of the recall. The FDA in April said infusion pumps, including Colleague, have been the source of “persistent safety problems.”
Infusion pumps deliver fluids, medicines and nutritional liquids via a timing mechanism that controls the amount of necessary medication a patient receives. In the last five years, the FDA said it received more than 56,000 reports of adverse events that have included serious injuries and more than 500 deaths linked to infusion pumps. The agency did not say how many adverse events were linked to the Colleague brand.
The problems with infusion pumps involve malfunctions such as software defects, user interface problems and electrical failures that could lead to electric shocks or failure to properly deliver the correct amount of fluids. Baxter has been operating under a 2006 consent decree that allowed the FDA to recall the pumps.
Before the FDA ordered the recall, the pumps were on the U.S. market but Baxter has not sold or distributed them for five years. In Colleague’s last full year on the market, it generated $170 million in annual sales.
The FDA said Baxter will “complete the recall and the replace or refund programs by July 14, 2012.” Baxter said in a statement today that Colleague pump owners may receive “the lesser pumps depreciated value, which will be no less than $1,500 per single-channel pump and $3,000 per triple-channel pump, or the purchase price.”
