By Bruce Japsen | The U.S. Food and Drug Administration 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.

The FDA said the Deerfield-based drug and device maker must “recall and
destroy” all of its Colleague pumps, saying the action is based on “a
longstanding failure” of the company to correct serious problems with
the pumps. Baxter will incur a special pretax special charge of $400
million to $600 million in the first quarter to cover the cost of the
recall.

“The situation has languished far beyond what it should have,” said Baxter chairman and chief executive officer Bob Parkinson, speaking this morning to company shareholders attending the company’s annual meeting in Deerfield.

Infusion pumps are devices most commonly found in hospitals, delivering fluids, medicines and nutritional liquids via a timing mechanism that controls the amount of necessary medication a patient receives.

The FDA said infusion pumps, including Baxter’s Colleague, have caused “persistent safety problems.”

In the last five years alone, the FDA said it has received more than 56,000 reports of adverse events that have 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, requiring manufacturers to perform more device tests before the devices are sold. The next week, Baxter rival Hospira, which is based in Lake Forest, said it was “proactively” ceasing sales of its infusion pump Symbiq, after customers complained 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 said it had rejected Baxter’s corrective action plan for the Colleague pumps, calling the plan “unacceptable” and saying it would have allowed the company to keep a device with “known safety concerns” on the market until 2013. The agency 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 issued Monday night. “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. Though Colleague pumps remain on the U.S. market, Baxter has not been selling or distributing them for five years. In Colleague’s last full year on the market, the device generated $170 million in annual sales.
 
The Deerfield-based medical product giant said it worked with the FDA to minimize disruption to hospitals using the Colleague brand pumps. The company will be offering health care facilities the opportunity to exchange the pumps without a charge to customers.

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.”