The U.S. Food and Drug Administration (FDA) announced June 29 that Baxter Healthcare Corp. (Baxter) and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.

Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. They are used in situations where medication must be administered intravenously or through other routes, in a continuous or intermittent manner, for a prolonged period of time.

"Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients. But if they don't work properly, patients are put at risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "Baxter has clearly had significant problems with some its infusion pumps. With this action today, Baxter has agreed to correct those problems. FDA's goal is to see that the necessary corrections are made, that the public health is protected and that users have access to safe and effective pumps."


Under the terms of the consent decree, signed by Baxter's Chairman and Chief Executive Officer, Robert L. Parkinson, Jr., and its Corporate Vice President and President of Medication Delivery Services, Peter J. Arduini, the company has agreed to take necessary measures to ensure compliance with the CGMP and QS requirements by all of its facilities that manufacture, process, pack, label, hold or distribute the Colleague and Syndeo Pumps. The decree also requires Baxter to retain an independent expert consultant to conduct inspections of its infusion pump facilities and certify to FDA that corrections have been made. FDA will continue to monitor these activities through its inspections.

Under the consent decree, FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. Baxter is also required to submit to FDA an acceptable detailed corrective action plan to bring the Colleague and Syndeo Infusion Pumps currently in use in the United States into compliance with the Federal Food, Drug, and Cosmetic Act (the Act). The agency recently issued a Preliminary Public Health Notification dated April 28, 2006 with recommendations for users, titled "Important Safety Recommendations for Baxter's COLLEAGUE Infusion Pumps" (see http://www.fda.gov/cdrh/safety/042806‑baxter.html).

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