The FDA has announced that Baxter Healthcare Corp 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. The company has agreed to stop manufacturing and distributing within the United States all models of its Colleague Volumetric Infusion Pump, and the Syndeo Patient Controlled Analgesic Syringe Pump until they correct manufacturing deficiencies, and until the devices are made in compliance with the FDA’s current good manufacturing practice requirements and the quality system regulation for devices.
“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, MD, 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. The 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 CEO, Robert L. Parkinson Jr, and corporate VP and President of medication delivery services, Peter J. Arduini, the company has agreed to take the necessary measures to ensure compliance with the current good manufacturing practice and quality system 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 the FDA that corrections have been made. The FDA will continue to monitor these activities through its inspections.
For more information: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01402.html.