Recalling Firm / Manufacturer

Baxter Healthcare Corp.

Product

Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8163, 2M9163

Code Information

Reason of Recall

A software anomaly is causing newly upgraded Colleague Triple Channel Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. This occurs during user programming with all three channels simultaneously infusing fluids. In reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.

Date Recall Initiated

June 20, 2007

Action

Baxter telephoned the direct accounts on 6/20-21/07, informing them that Baxter has 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 simultaneously infusing fluids. In all cases, the pump stopped the infusions and both an audible and visual alarm notification were activated. The accounts were requested to immediately remove the affected triple channel pumps, identified by two attached hangtags entitled "Battery" and "Power On", from service. The accounts were informed that their Baxter representative 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, if available. Baxter sent follow-up Urgent Product Recall letters dated 6/22/07. Firm Initiated recall is ongoing.

Contact

Arabian Health Care Supply Co. (AHCSC)
Riyadh
(01) 4747444

Source of Information

U.S FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.