BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-ID

    MDR report key: 2732985 · Received September 4, 2012

    Report

    Report Number
    8010762-2012-00033
    Event Type
    Death
    Date Received
    September 4, 2012
    Date of Event
    July 23, 2012
    Report Date
    August 9, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET (B)(4). MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE FACILITY MEDWATCH STATE LOT #70075847, HOWEVER, DURING F/U WITH THE FACILITY IT WAS NOTED THAT TWO OXYGENATORS WERE USED BUT THEY WERE UNABLE TO DETERMINE WHICH ONE WAS INVOLVED IN THE INCIDENT. ADDITIONALLY, THE LOT #'S USED WERE 70072248 AND 70079206 AND NOT LOT #70075847.

    Description of Event or Problem · 1

    EVENT DESCRIPTION FROM THE HOSP - "THE PT WAS IN THE CARDIAC INTENSIVE CARE UNIT (CICU), ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE MEDICAL TEAM HAD FINISHED THE SECOND EVAL FOR BRAIN DEATH WHICH WAS CONSISTENT WITH BRAIN DEATH. THEY WERE AWAITING RESULTS OF A PRIOR EEG. A PHYSICIAN LIFTED AND LOWERED THE HEAD OF THE PT'S BED. THIS APPEARS TO HAVE CAUSED A PART OF THE MAQUET POST OXYGENATOR. CONNECTION OUTLET TO BREAK IN TWO, CAUSING A DISRUPTION IN THE ECMO CIRCUIT WITH RAPID BLOOD LOSS. ONE OF THE PHYSICIANS RE-ATTACHED THE PARTS LEAVING ONLY A SMALL DRIPPING OF BLOOD. DURING THIS EVENT, IT WAS LEARNED THAT THE PRIOR EEG CONFIRMED BRAIN DEATH AND THE PT WAS PRONOUNCED DEAD". F/U WITH THE FACILITY ON (B)(4) 2012: THIS WAS NOT A FAILURE OF THE OXYGENATOR. WHEN THE HEAD OF THE BED WAS BEING LOWERED ONE OF THE ARM RAILS HIT THE OUTLET AND BROKE IT OFF. THE PT HAD BEEN ON SUPPORT SINCE (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-ID OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death