BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR ELIMINATING SPIKE

    MDR report key: 3379083 · Received September 25, 2013

    Report

    Report Number
    MW5032044
    Event Type
    Malfunction
    Date Received
    September 25, 2013
    Date of Event
    September 23, 2013
    Report Date
    September 24, 2013
    Manufacturer
    BAXTER HEALTHCARE SA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CALLED TO ROOM BY PT WHO STATED "I HAVE A TUBING ISSUE." UPON ENTERING ROOM FOUND PT HOLDING END OF PCA TUBING WHICH HAD BECOME TORN FROM OTHER PART OF TUBING STILL IN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484353 AIR ELIMINATING SPIKE PUMP IV TUBING & FILTER FPA BAXTER HEALTHCARE SA UR12G12147

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR