BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON PUMP

    MDR report key: 1890451 · Received November 3, 2010

    Report

    Report Number
    1723533-2010-00009
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 28, 2010
    Manufacturer
    WALKMED INFUSION
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY WAS TESTING THE PUMP PRIOR TO INITIAL USE IN THE CLINIC AND FOUND THE PUMPS WERE OVER DELIVERING BY APPROX 8.5% COMPARED TO +/- 5% EXPECTED. THE PUMP HAD NOT BEEN USED IN A CLINICAL SETTING AND THERE WAS NO PT INVOLVEMENT. THE CONDITION WAS CONFIRMED BY THE MANUFACTURER ON THIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITON PUMP INFUSION PUMP FRN WALKMED INFUSION 300000

    Patients

    Seq Age Sex Outcome Treatment
    1