BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER DIALYSIS MACHINE

    MDR report key: 38757 · Received September 6, 1996

    Report

    Report Number
    38757
    Event Type
    Death
    Date Received
    September 6, 1996
    Date of Event
    August 21, 1996
    Report Date
    September 6, 1996
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE AND ONE HALF HRS INTO A HEMODIALYSIS TREATMENT THE PT EXPERIENCED A CARDIAC ARREST AND DIED. SHE WAS DIALYZING ON A ZERO POTASSIUM BATH. HER LAST POTASSIUM LEVEL ON 3/5 WAS 6.0. SHE HAD BEEN SUBSEQUENTLY PLACED ON A POTASSIUM RESTRICTED DIET AND HAD 2 LAXATIVES THE EVENING PREVIOUS TO THIS EVENT. THE MACHINE WAS CHECKED FOR FUNCTIONING AND FOUND TO HAVE DISCREPANCIES IN DIALYSATE AND BLOOD FLOW RATES AS WELL AS BLOOD LEAK DETECTOR. THE MFR WAS CALLED TO CHECK OUT THIS MACHINE. DFR AT 875 CC/MIN NOT 700 CC AS SET. BRF = "OK". FACILITY TECH FOUND 620 AT 300 SETTING. BLD LEAK DET TESTS AT 120 O'CLOCK. SHOULD BE AT 9 O'CLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER DIALYSIS MACHINE 500 FKP BAXTER HEALTHCARE CORP. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death
    2
    3