BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX D

    MDR report key: 2102988 · Received April 28, 2011

    Report

    Report Number
    8010762-2011-00002
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 (B)(4). MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE IN THIS REPORT. BEING INVESTIGATED. BASED ON THE CURRENT INFO, THE EXACT CAUSE OF THE EVENT IS UNDETERMINED. ADDITIONAL INFO ABOUT THE COAGULATION PROFILE AND THE PERFUSION RECORDS HAVE BEEN REQUESTED. ONCE ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. ITEMS MARKED NI ARE UNK TO US AT THIS TIME. MFR. REPORT#: 8010762-2011-00002. (B)(4). ADDITIONAL INFO FROM THE IMPORTER REPORT: MAQUET CARDIOVASCULAR IS SUBMITTING AN ADDITIONAL INITIAL REPORT AS THE UF/IMPORTER REPORTER.

    Description of Event or Problem · 1

    OXYGENATOR FAILED DURING ECMO BECAUSE OF CLOTTING AFTER 12 HOURS. THE PT SUFFERED FROM WHIPPLES DISEASE. NO KNOWLEDGE OF BLOOD PARAMETERS OR THE PT'S COAGULATION PROFILE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D NONE DTZ MAQUET CARDIOPULMONARY AG NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death