BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CONTROLLED ANALGESIA PUMP

    MDR report key: 1213424 · Received October 15, 2008

    Report

    Report Number
    1213424
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 21, 2008
    Report Date
    October 15, 2008
    Manufacturer
    B BRAUN MEDICAL INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF NOT GETTING RELIEF FROM PCA MEDICATION. RN REALIZED THAT MOST OF THE MEDICATION WAS STILL IN THE BAG. FURTHER ASSESSMENT REVEALED THAT THE PCA BUTTON WAS NOT WORKING (I.E. WHEN PUSHED PT DID NOT RECEIVE BOLUS). BIOMEDICAL ENGINEERING TESTED THE PUMP AND IDENTIFIED A BROKEN CABLE AS THE SOURCE OF THE PROBLEM. THIS HAS BEEN A FREQUENT PROBLEM WITH THESE PUMPS. BIOMED BELIEVES THE CABLE SHOULD BE DESIGNED TO BE MORE FLEXIBLE. WE ARE ALSO REMINDING OUR STAFF NOT TO TIGHTLY WRAP THE CORDS FOR STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT CONTROLLED ANALGESIA PUMP PUMP, PCA MEA B BRAUN MEDICAL INC. * 3509010B

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES| NO OTHER THERAPIES