June 29, 2006 — /FDA News/ — The U.S. Food and Drug Administration (FDA) today announced 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).
If corrective action under the decree is completed and Baxter has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its domestic infusion pump facilities at least once a year for at least four years. Results of these audit inspections will be reported directly to FDA. If Baxter fails to comply with any provision of the decree, or violates the Act or FDA regulations, FDA may order the firm to again stop manufacturing and distributing, recall the products or take other action.
The most recent FDA inspection of Baxter’s Round Lake Facility, conducted on June 20-30, 2005, revealed deficiencies with the CGMP and QS requirements for devices, including the firm’s failure to implement adequate management controls over its quality system operations and corrective and preventive actions (CAPA) procedures. During this inspection, design defects relating to the reliability of both the Colleague and the Syndeo Infusion Pumps were also revealed.
During the course of FDA’s June inspection, Baxter initiated a voluntary world-wide hold on all Syndeo Infusion Pumps due to design defects that can cause the device to stop functioning. Also during the June inspection, Baxter initiated a voluntary world-wide hold on all Colleague Infusion Pumps due to a product design defect relating to a temperature sensitive component of the device’s timing circuit, known as the Y2A crystal, which causes the timing circuit to fail.
Before the June 2005 inspection, FDA conducted two previous inspections of Baxter’s medication delivery systems facility in Round Lake, Illinois, in September 2000 and June 2002, all of which revealed lack of management controls over the firm?s quality system operations and inadequacy of its CAPA and complaint handling systems. These deficiencies undermined Baxter’s ability to assure the quality of the devices manufactured at its Singapore plant. In September 1999, FDA issued a Warning Letter to the firm addressing its lack of CAPA procedures. In August 2001, another Warning Letter was issued to Baxter addressing deficiencies in its CAPA procedures.
The consent decree also resolves the disposition of Colleague and Syndeo Infusion Pumps that were seized by the Department of Justice on behalf of FDA in October 2005. The consent decree was entered today by the U.S. District Court for the Northern District of Illinois.
Catherine McDermott, 301-827-6242