BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2141753 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-08983
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH "THE MACHINE CHANGED FROM PRIMARY MODE TO SECONDARY MODE" WAS CONFIRMED DURING PRODUCT EVALUATION. IT WAS DETERMINED THAT USER ERROR CONTRIBUTED TO THIS EVENT. THEREFORE, NO REPAIR WAS NECESSARY TO CORRECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP CHANGED FROM PRIMARY MODE TO SECONDARY MODE. THIS EVENT MAY HAVE BEEN AN OVERINFUSION. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1