BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008K MACHINE

    MDR report key: 3350209 · Received August 19, 2013

    Report

    Report Number
    3350209
    Event Type
    Death
    Date Received
    August 19, 2013
    Date of Event
    July 27, 2013
    Report Date
    August 12, 2013
    Manufacturer
    FRESENIUS NA USA
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT ON DIALYSIS MACHINE WITH 2 MINUTES LEFT OF TREATMENT BECAME BRADYCARDIC AND THEN CODED. HD NURSE RETURNED BLOOD AND CAPPED CATHETER. PATIENT ON 0 K+ FOR 1 HOUR AND THEN 1 K+ FOR 2 HOURS. MACHINE FAILED POST FUNCTIONAL TEST. MACHINE FAILED UF CONTROL FUNCTION AND THE OPTICAL DETECTOR POST EVENT. MACHINE FAILED THE POSITIVE PRESSURE TEST ON THE HYDRAULICS, AND THE POSITIVE PRESSURE TEST ON THE UF PUMP POST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400580 FRESENIUS 2008K MACHINE FRESENIUS DIALYSIS MACHINE KDI FRESENIUS NA USA M35980

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death DIALYZER F160| COMBI-SET