Baxter Healthcare Corp. agrees to correct deficiencies

08/01/2006

The U.S. Food and Drug Administration (FDA) recently 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. 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, which are electronic devices intended to control delivery of solutions and medications to patients, 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.

“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,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health.

Under the terms of the consent decree, 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.

The most recent FDA inspection of Baxter’s Round Lake, Illinois, facility, conducted in June 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 worldwide hold on all Syndeo and Colleague Infusion Pumps.

Two previous inspections of Baxter’s Round Lake facility, in September 2000 and June 2002, revealed lack of management controls over the firm’s quality system operations and inadequacy of its CAPA and complaint handling systems. In September 1999, FDA issued a Warning Letter to the firm addressing its lack of CAPA procedures. In August 2001, another Warning Letter addressing deficiencies in its CAPA procedures was issued to Baxter.