BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008T

    MDR report key: 5922295 · Received August 31, 2016

    Report

    Report Number
    5922295
    Event Type
    Death
    Date Received
    August 31, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 22, 2016
    Manufacturer
    FRESENIUS RTG
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE AND HALF HOURS INTO HEMODIALYSIS TREATMENT, PT WAS FOUND UNRESPONSIVE. CPR INITIATED, AED APPLIED WITH NO SHOCK ADVISED. EMS TRANSPORTED PT TO HOSPITAL WHERE SHE EXPIRED. MACHINE PASSED FUNCTIONAL TESTING POST EVENT, HOWEVER, IT WAS NOTED TWO BLOOD PRESSURES WERE RECORDED DURING THIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570698 FRESENIUS 2008T HEMODIALYSIS MACHINE KDI FRESENIUS RTG 2008T

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 180NRE OPTIFLUX DIALYZER| COMBISET HEMODIALYSIS LINES