BEUDAMED
    FDA Recall Terminated

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    Recall: Z-0345-05 · Initiated November 4, 2004

    Recall

    Recall Number
    Z-0345-05
    Event Number
    30381
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2004
    Posted
    December 22, 2004
    Terminated
    February 2, 2011
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    Reason

    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.

    Action

    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.

    Distribution

    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.