BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRITON PUMP

    MDR report key: 1813082 · Received July 21, 2010

    Report

    Report Number
    1723533-2010-00006
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 16, 2010
    Manufacturer
    WALKMED INFUSION
    Product Code
    FRN
    PMA / PMN Number
    K070529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY WAS TESTING 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 PATIENT INVOLVEMENT.

    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