BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG

    MDR report key: 2120333 · Received May 27, 2011

    Report

    Report Number
    2120333
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    WHEN Y CLAMP OPENED UP ON ONE SIDE, A CONTINUOUS BUBBLING OF AIR WAS NOTED IN THE RESERVOIR. NO BLOOD COULD BE RETURNED TO PATIENT BECAUSE BOWL INTO WHICH CELL SAVER WAS ATTACHED TO WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOLOG AUTOTRANSFUSION SYSTEM CAC MEDTRONIC 13110 11206363

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR