The Food and Drug Administration has ordered Baxter International Inc. to recall 200,000 of the company's Colleague brand pumps, escalating its scrutiny of infusion pumps used primarily in hospitals to deliver fluids to patients.
The FDA said the Deerfield, Ill.-based drug and device maker 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. Baxter will incur a special pretax charge of $400 million to $60 million in its first quarter to cover the cost of the recall.Receive breaking news alerts on your mobile device. Register »
The FDA said the Deerfield, Ill.-based drug and device maker 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. Baxter will incur a special pretax charge of $400 million to $600 million in its first quarter to cover the cost of the recall.
"The situation has languished far beyond what it should have," said Bob Parkinson, Baxter's chairman and chief executive, speaking Tuesday to shareholders attending the company's annual meeting in Deerfield.
Infusion pumps are devices most commonly found in hospitals, delivering fluids, medicine and nutritional liquids via a timing mechanism that controls the amount of medication a patient receives.
The FDA said infusion pumps, including Baxter's Colleague, ad caused "persistent safety problems."
In the last five years, the FDA has received more than 56,000 reports of adverse events that included serious injuries and more than 500 deaths. The agency did not say how many adverse events were linked to Baxter's Colleague pump.
On April 23, the FDA launched a new initiative to address infusion pump safety that required manufacturers to perform more tests before the devices are sold. The next week, Baxter rival Hospira of Lake Forest, Ill., said it was ceasing sales of its infusion pump Symbiq after customers complained that the alarm failed "at the end of infusion in certain conditions."
Parkinson said the kind of design improvements the FDA wanted were "close to impossible" for Baxter to accomplish "without fundamentally redesigning the pump."
By the end of last week, the FDA had rejected Baxter's corrective action plan for the Colleague pumps. 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."
Baxter has been operating under a 2006 consent decree with the FDA that allowed the agency to recall the pumps. Although Colleague pumps remain on the U.S. market, Baxter has not sold or distributed them for five years. In Colleague's last full year on the market, the device generated $170 million in sales.
The medical product giant said it worked with the FDA to minimize disruption to hospitals using the Colleague pumps. The company will be offering healthcare facilities the opportunity to exchange the pumps without charge.
Baxter will offer to exchange its Sigma Spectrum infusion pumps for the Colleague brand. Baxter spokeswoman Erin Gardiner described the Sigma Spectrum as a next-generation "smart pump."sports
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