BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2342058 · Received November 18, 2011

    Report

    Report Number
    6000001-2011-38055
    Event Type
    Malfunction
    Date Received
    November 18, 2011
    Date of Event
    October 24, 2011
    Report Date
    October 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K041191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4) . THE CAUSE OF THE ERROR WAS A SELECTION STATEMENT DEFAULT. TO CORRECT THIS CONDITION THE MANUAL TUBE RELEASE WAS CLOSED; NO FURTHER REPAIR WAS DEEMED NECESSARY TO CORRECT THIS CONDITION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A FAILURE CODE 4:311:3686:001D ON CHANNEL A. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER. "THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT." THIS INVOLVED AN UNREMEDIATED INFUSION PUMP WITH USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1