Class 1 Recall: Baxter Healthcare Corp. Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps

June 20, 2007

See also:

December 13, 2005, Recall for Baxter COLLEAGUE® and COLLEAGUE® CX Volumetric Infusion Pumps
http://www.fda.gov/cdrh/recalls/recall-121305.html

Upgraded Colleague® Triple Channel Volumetric Infusion Pumps, Model Numbers 2M8153, 2M8163, and 2M9163

From May 14, 2007 through June 18, 2007, Baxter distributed 4,512 infusion pumps to 420 customers (distributors and medical facilities) within the U.S. and to 7 customers outside the U.S.

Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream.

A software irregularity causes the newly upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion in all three channels. This occurs during user programming with all three channels infusing fluids at the same time. In reported cases, the pump stopped infusing which caused it to activate an audible and a visual alarm.

• From June 20, 2007 through June 21, 2007, Baxter telephoned their customers and informed them that Baxter had received multiple reports of newly upgraded COLLEAGUE® Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion.
  
• These reported events occurred during user programming with all three channels infusing fluids at the same time. In all cases, the pump stopped the infusions in all three channels, which caused it to activate an audible and visual alarm.
  
• Baxter requested that all of the affected triple channel pumps be immediately removed from service. These pumps were identified by two attached hangtags entitled “Battery” and Power On.”
  
• Baxter informed their customers that representatives would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps.
  
• COLLEAGUE® customers with questions may contact Baxter’s Medical Delivery Services at 1-800-843-7867.
  
• For more information about this recall, please see the company’s press release at: http://www.baxter.com/about_baxter/news_room/news_releases/2007/07-18-07-colleague.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178