BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS 2008 K2

    MDR report key: 3771103 · Received November 26, 2013

    Report

    Report Number
    3771103
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    November 24, 2013
    Report Date
    November 26, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALINE BAG INAPPROPRIATELY FILLING ON FRESENIUS 2008 K2 HEMODIALYSIS MACHINE. PT WAS PUT ON MACHINE AND TREATMENT STARTED BEFORE THE PROBLEM WAS NOTED. PT WAS ASYMPTOMATIC, TX WAS STOPPED, DID NOT RINSE BACK, MACHINE PULLED. TX RESUMED ON NEW SET UP AND NEW MACHINE. MFR REF # 2937457-2013-00580.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618018 FRESENIUS 2008 K2 DIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE 2008 K2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR FRESENIUS COMBISET 8 MM BLOOD LINES| FRESENIUS OPTIFLUX 160NRE DIALYZER