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FDA Hits Baxter on Pump Failures

Oct 15, 2005 | Chicago Sun Times

Baxter International failed to properly inform U.S. regulators about problems with its medical infusion pumps, which have been linked to patient deaths, and the company violated manufacturing requirements, the Food and Drug Administration alleged Friday.

The agency, in a statement released Friday, also contended Deerfield-based Baxter failed to take appropriate actions to correct the violations.

The pumps are used to administer medicines and intravenous fluids to patients in hospitals and alternative care sites. Defects can cause the devices to unintentionally shut down.

"We're working diligently with the FDA to address all of their concerns," Baxter spokeswoman Cindy Resman said.

An FDA spokeswoman declined to provide information on possible penalties Baxter could face, noting the investigation is continuing.

On Thursday, Baxter said the agency had seized nearly 7,000 of its company-owned pumps, including 6,000 Colleague infusion pumps and 850 Syndeo syringe pumps that were on hold at company sites in Buffalo Grove and Waukegan.

The FDA said U.S. marshals seized 4,000 Syndeo and Colleague infusion pumps from Baxter's warehouse in Buffalo Grove and 135 Syndeo pumps from its distributor's warehouse in Waukegan.

Resman said Friday the nearly 3,000 remaining pumps are on hold at a company site.

No products were seized from health care facilities or individual users, and the FDA said there are no plans to do so. Health care facilities can continue to use pumps in their possession, guided by instructions Baxter previously provided them, the agency said, while adding that users should recognize the types of problems that could occur and have a backup plan.

Baxter is repairing the roughly 250,000 Colleague infusion pumps and 5,000 Syndeo infusion pumps in use worldwide.

Baxter halted shipments of the popular pumps in July after determining that flaws in the Colleague pumps might have resulted in three deaths and six serious injuries. The company took a $65 million charge in the second quarter because of its remediation actions.

Last month, Baxter said as many as seven deaths might be linked to the problem pumps, and the FDA categorized the voluntary notices sent out by the company to Colleague pump users early this year as "Class 1" recalls a serious designation, but one that doesn't require Baxter to pull the products from the market.

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