Baxter Healthcare Signs Consent Decree

July 6, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration (Rockville, MD) announced that Baxter Healthcare Corp. (Deerfield, IL) signed a consent decree relating to the company's "Colleague" volumetric infusion pump and "Syndeo" patient-controlled analgesic syringe pump.

The US Food and Drug Administration (Rockville, MD, www.fda.gov) announcedthat Baxter Healthcare Corp. (Deerfield, IL, www.baxter.com)signed a consent decree relating to the company's "Colleague"volumetric infusion pump and "Syndeo" patient-controlled analgesicsyringe pump. Baxter will cease the manufacture and US distribution ofboth pumps until the company corrects manufacturing deficiencies andensures that the devices comply with FDA's CGMP requirements and thequality system (QS) regulation for devices. Baxter also must hire anindependent expert consultant to inspect its infusion-pump facilitiesand confirm to FDA that corrections have been made.

FDA will allow Baxter to keep providing routine service maintenance andto replace components and accessories for the Colleague and Syndeopumps customers bought before Oct. 12, 2005. Baxter must provide FDAwith a corrective action plan for bringing the devices currently in useinto compliance with the Federal Food, Drug, and Cosmetic Act. Theagency issued a Preliminary Public Health Notification dated April 28,2006 with recommendations for users, titled "Important SafetyRecommendations for Baxter's COLLEAGUE Infusion Pumps" (see http://www.fda.gov/cdrh/safety/042806-baxter.html).

FDA conducted its latest inspection of Baxter's Round Lake facility onJune 20-30, 2005. The inspection uncovered faults such as Baxter'sfailure to establish sufficient management controls over its QSoperations and corrective and preventive actions procedures. FDAdiscovered a design defect that causes the Syndeo device to stopfunctioning. The inspection also revealed a design defect related tothe Colleague pump's temperature-sensitive Y2A crystal component thatcauses the unit's timing circuit to fail.

If Baxter completes corrective action and is allowed to resumemanufacturing and distribution of the pumps, the firm will hire anindependent auditor to conduct inspections of its domestic infusionpump facilities at least once a year for at least four years. Theauditor will report the results of the inspections directly to FDA. IfBaxter fails to comply with any provision of the decree or violates theAct or FDA regulations, FDA may order the firm again to stopmanufacturing and distributing, recall the products, or take otheraction.