BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXYGENATOR, CARDIOPULMONARY BYPASS

    MDR report key: 5008164 · Received August 14, 2015

    Report

    Report Number
    8010762-2015-00881
    Event Type
    Death
    Date Received
    August 14, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 30, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K1011153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT AVAILABLE FOR MANUFACTURER'S LABORATORY INVESTIGATION AS IT WAS SCRAPPED BY THE HOSPITAL. THEREFORE A CONFIRMATION OF THE FAILURE IS NOT POSSIBLE. THREE WERE PERFORMED IN ORDER TO REQUEST THE PRODUCTS UDI (UNIQUE DEVICE IDENTIFIER) FOR A DEVICE HISTORY RECORD REVIEW. ADDITIONALLY, FURTHER INCIDENT INFO WAS REQUESTED BY OUR CLINICAL APPLICATION SPECIALIST. NO INFO WAS PROVIDED UP TO DATE. BASED ON THE INCIDENT INFORMATION PROVIDED IT WAS TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MANAGEMENT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537618 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG 70104495

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R