BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS

    MDR report key: 5009813 · Received August 13, 2015

    Report

    Report Number
    5009813
    Event Type
    Death
    Date Received
    August 13, 2015
    Date of Event
    April 18, 2015
    Report Date
    June 25, 2015
    Manufacturer
    PMC
    Product Code
    KPO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    APPROX 1 HOUR 45 MINUTES INTO TREATMENT, PT BECAME BRADYCARDIC TOGETHER WITH SHORTNESS OF BREATH. MD NOTIFIED, ORDERS RECEIVED TO DISCONTINUE TREATMENT AT THAT TIME. PT DNR. PT EXPIRED 10 MINS AFTER TREATMENT COMPLETED. MACHINE FAILED THE MACHINE TEMPERATURE FUNCTION TEST POST TREATMENT. MFR # 2937457-2015-01306.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533181 FRESENIUS DIALYSIS MACHINE KPO PMC 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death