Recalls / —

—#40539

Product

Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8151, 2M8151R, 2M8161, 2M8161R

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K041191

Affected lot / code info

all serial numbers

Why it was recalled

A hardware problem can cause internal communications errors which halt therapies, generate alarms and communication failure codes.

Root cause (FDA determination)

Device Design

Action the firm took

Baxter sent the 7/20/05 Urgent Product Recall letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via overnight delivery to alert them of a patient death which may have been associated with an electronic failure resulting from a design issue with the pump, and listed failure codes 402, 403, 532, 533, 534, 535, 702, 703, 704, 720, 804:22, 804:24, 804:29, 804:34, 804:52, 804:54, 804:58 and 12:303:xxx:0006 that may be related to the electronic failure. The users were advised to have a contingency plan to mitigate any disruptions of infusions of life sustaining drugs if the listed failure codes occur, and to take the pump out of service. They were also requested to review the event history of their pumps and take any pump with a previous history of the listed failures out of service. The accounts were also advised that all pumps processed through Baxter's service operations will be checked for the listed failure codes, and if a pump is found to have any of the codes in its event history, it will not be returned until a corrective action has been implemented. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.

Recalling firm

Firm

Baxter Healthcare Corp. Rt.

Address

120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern

Nationwide including Puerto Rico, and internationally to Australia, the Bahamas, Bahrain, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, the United Arab Emirates and teh United Kingdom.

Timeline

Recall initiated

2005-07-20

Posted by FDA

2005-08-10

Terminated

2011-06-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40539. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.