—#35773

Product

Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002211, K003616
Affected lot / code info: all serial numbers

Why it was recalled

A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent Urgent Device Correction letters dated 11/4/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the 12:303 failure and possible interruption of patient therapy when it occurs. They were informed that new software was available to address the failure alarm code with the infusion pumps, and that the software also included updates to the predefined label library and the addition of a text message 'Close regulating roller clamp' to the manual tube release pop-up message. The software is being installed on all single and triple channel Colleague infusion pumps as they are processed through Baxter''s depot repair centers for other repair actions or routine maintenance. An Operator''s Manual Addendum was included with the letter to reflect the changes to the label library and the manual tube release pop-up message. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of revised software installation kits needed by self-service customers. Any questions were directed to Baxter at 1-800-843-7867.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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

Timeline

Recall initiated: 2004-11-04
Posted by FDA: 2004-12-22
Terminated: 2011-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35773. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.