BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER PAIN PUMP 2 BLOCK AID

    MDR report key: 1220683 · Received November 3, 2008

    Report

    Report Number
    MW5008856
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 3, 2008
    Manufacturer
    STRYKER
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE STRYKER PUMP WAS INADVERTENTLY TURNED ON DURING THE FILLING OF THE RESERVOIR. THE TECHNICIAN TURNED THE PUMP OFF, FOLLOWING THE DIRECTIONS ON THE PUMP. WHEN THE PUMP FILLING WAS COMPLETE, THE TECHNICIAN NOTICED THAT THE SCREEN WAS BLANK EXCEPT IN THE LOWER RIGHT CORNER WHERE THE DISPLAY WAS "3 ML". THE PUMP HAD NOT BEEN RUNNING. THE TECH TRIED TO CLEAR THE SCREEN BY TURNING IT ON THEN OFF, BUT IT WOULD NOT TURN BACK ON. AT THAT POINT WE CONSIDERED IT FAILED. I CALLED THE COMPANY AND THE TECH SUPPORT SEEMED TO KNOW THE PROBLEM AND ASKED THAT WE SAVE THE PUMP FOR THE REP TO PICK UP SO THEY COULD EVALUATE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAIN PUMP 2 BLOCK AID NONE MEA STRYKER 08259022

    Patients

    Seq Age Sex Outcome Treatment
    1