BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX D

    MDR report key: 1909960 · Received November 19, 2010

    Report

    Report Number
    8010762-2010-17110
    Event Type
    Death
    Date Received
    November 19, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOVASCULAR SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG, (B)(4). BEING INVESTIGATED. SO FAR, THE DEATH CANNOT BE RELATED TO OR BE BLAMED FOR THE OXYGENATOR FAILURE. ADDITIONAL INFORMATION ABOUT THE COAGULATION PROFILE AND THE PERFUSION RECORDS HAVE BEEN REQUESTED, BUT HAVE NOT YET BEEN PROVIDED. MFR. REPORT#: 8010762-2010-17110. (B)(4). (B)(4). ADDITIONAL LOT#: 70042829.

    Description of Event or Problem · 1

    THREE OXYGENATORS FAILED DURING ECMO BECAUSE OF CLOTTING. THE PT WAS ON THE LUNG TRANSPLANT LIST. STARTED TO DETERIORATE AND SO, ECMO WAS INSTITUTED URGENTLY IN THE OPERATING ROOM. THE LENGTH OF TIME ON ECMO WAS ROUGHLY 36 HRS. NO KNOWLEDGE OF BLOOD PRODUCTS USED OR THE PT'S COAGULATION PROFILE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D QUADROX DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD 2030 70023580

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death