At the request of the U.S. Food and Drug Administration (FDA), on October 12, 2005, the U.S. District Court for the Northern District of Illinois issued a warrant for the seizure of three types of infusion pumps manufactured by Baxter Healthcare Corporation.
The pumps were seized because FDA inspections revealed that the firm has continually failed to follow medical device manufacturing requirements.
Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. Pump shutdown could result in serious injuries or death to critically ill patients who depend on continuous infusion medications and/or life-sustaining medications. The seized products are:
· SYNDEO PCA Syringe Pumps
· Colleague Volumetric Infusion Pumps
· Colleague CX Volumetric Infusion Pumps
Baxter has distributed these products worldwide.
Four thousand SYNDEO and Colleague infusion pumps were seized by the U.S. Marshals Service from Baxter’s warehouse in Buffalo Grove, IL, and 135 SYNDEO pumps from a distributor’s warehouse in Waukegan, IL. No products were seized from healthcare facilities or individual users, and there are no plans to do so.
Healthcare facilities can continue to use pumps in their possession, but should have a backup plan in place, especially in situations where the pump is part of a life-saving function.
Baxter was previously issued Warning Letters from the FDA outlining the violations. Per the FDA, Baxter was given an opportunity to correct the violations, but failed to take appropriate actions. On February 25, March 15, July 6, and July 20, 2005, Baxter notified the public of the potential health hazard associated with these products.
The FDA alleges that none of the seized infusion pumps were manufactured under the proper controls and that the Colleague pumps have a design defect that may cause the pumps to stop and shut down during infusion therapy. Further, the FDA believes Baxter failed to inform the FDA of the Colleague infusion pump failures, in violation of the Medical Device Reporting regulation of the Federal Food, Drug and Cosmetic Act.
Baxter Corporation issued a news release last week addressing the charges made by the FDA. The company stated that they have developed an aggressive corrective action plan and remain in discussions with the FDA concerning the infusion pump issues.
“The quality of our products is our highest priority,” said Robert L. Parkinson, Jr., chairman and chief executive officer. “We are committed to working with the agency and our customers to resolve these issues as quickly as possible.”