BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON PUMP

    MDR report key: 2823676 · Received August 28, 2010

    Report

    Report Number
    1723533-2010-00011
    Event Type
    Malfunction
    Date Received
    August 28, 2010
    Date of Event
    July 10, 2010
    Report Date
    August 18, 2010
    Manufacturer
    WALKMED INFUSION
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBER: B)(4).

    Description of Event or Problem · 1

    USER FACILITY WAS TESTING 2 PUMPS PRIOR TO INITIAL USE IN THE CLINIC AND FOUND THE PUMPS WERE OVER DELIVERING BY APPROXIMATELY 6-8% COMPARED TO +/- 5% EXPECTED. THE PUMPS HAD NOT BEEN USED IN A CLINICAL SETTING AND THERE WAS NO PT INVOLVEMENT. THE CONDITION WAS CONFIRMED BY THE MFR FOR ONE PUMP, BUT NOT THE OTHER.

    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