BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI SET HEMODIALYSIS BLOOD TUBING LINES

    MDR report key: 4991292 · Received August 5, 2015

    Report

    Report Number
    4991292
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 5, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT CARE TECHNICIANS ATTEMPTED TO CANNULATE THE ARTERIAL SITE AND RE-ADJUST THE ARTERIAL NEEDLE TO OBTAIN BLOOD FLOW. AT THE TIME OF INITIATING TREATMENT, THE ARTERIAL CHAMBER WAS FILLED WITH SALINE BUT WHEN BLOOD REACHED THE ARTERIAL CHAMBER, IT STARTED EMPTYING AND FILLING WITH AIR. THE MACHINE ALARMED AND TECHNICIANS ATTEMPTED TO ASSESS AND TROUBLE-SHOOT BY RAISING THE LEVEL OF THE ARTERIAL CHAMBER WITH SALINE. PATIENT LOST CONSCIOUSNESS. AT THAT TIME, STAFF OBSERVED AN EMPTY SALINE BAG AND AIR IN THE DIALYSIS LINES. STAFF PLACED PATIENT IN TRENDELENBURG POSITION ON LEFT SIDE, APPLIED OXYGEN AND CALLING 911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518994 COMBI SET HEMODIALYSIS BLOOD TUBING LINES DIALYSIS BLOOD LINES FJK FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death ADVERSE EVENT". MACHINE PASSED ALL TESTS.