BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOPUMP PLUS WITH CARMEDA

    MDR report key: 1888346 · Received October 28, 2010

    Report

    Report Number
    2184009-2010-00028
    Event Type
    Death
    Date Received
    October 28, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 6, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    KFM
    PMA / PMN Number
    K973011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION REVEALED A MASSIVE CLOT BETWEEN THE BACKPLATE AND LOWER ROTATOR. THE BEARING CARTRIDGE WAS OFF CENTER OF THE MAGNET, AND DEFORMED. IN ADDITION, THERE WAS EVIDENCE OF MOISTURE INGRESS INTO THE MAGNET AREA. PERFORMANCE ANALYSIS COULD NOT BE PERFORMED, AS THE UNIT WAS NOT CONSIDERED FUNCTIONAL. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ABNORMALITIES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. CONCLUSION: THIS UNIT STOPPED DURING THE ECMO PROCEDURE DUE TO DAMAGE INDUCED BY A MASSIVE CLOT BETWEEN THE BACKPLATE AND LOWER ROTATOR. THE CLOT APPEARED TO HAVE CAUSED HIGH HEAT, WHICH DEFORMED THE BEARING CARTRIDGE OFF CENTER FROM THE MAGNET. IN ADDITION, DUE TO THE DEFORMATION IN THE SHAFT/CARTRIDGE AREA, MOISTURE INGRESS INTO THE MAGNET AREA WAS OBSERVED. THE MEDTRONIC BIO-PUMP SHOULD ONLY BE USED FOR PERIODS UP TO 6 HOURS PER THE INSTRUCTIONS FOR USE DOCUMENTATION. IN CONCLUSION, OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPUMP WAS USED ON A LONG EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE. AFTER DAY 16, THE PUMP DEVELOPED A CLOT, BEGAN TO VIBRATE AND CEASED PUMPING. THE PT EXPIRED WHILE ON ECMO FROM MULTIPLE ORGAN FAILURE. THE BIOPUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPUMP PLUS WITH CARMEDA KFM MEDTRONIC PERFUSION SYSTEMS CBBPX-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death