July 7, 2006

FDA ALERT

Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals that Baxter Healthcare will stop manufacturing and distributing all models of Colleague Volumetric Infusion Pump and Syndeo Patient Controlled Analgesic Syringe Pump until the company corrects manufacturing deficiencies and is in compliance with FDA's current good manufacturing practice requirements and the Quality System regulation for devices. 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. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. FDA issued a Preliminary Public Health Notification April 28, 2006 with recommendations for users, http://www.fda.gov/cdrh/safety/042806‑baxter.html.

Read the complete MedWatch 2006 Safety summary, including links to the FDA Press Release at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Colleague3