BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRAKE WILLOCK

    MDR report key: 61838 · Received January 8, 1997

    Report

    Report Number
    3019627-1996-00003
    Event Type
    Death
    Date Received
    January 8, 1997
    Date of Event
    December 3, 1996
    Report Date
    December 26, 1996
    Manufacturer
    ALTHIN MEDICAL, INC.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT MFR BY ALTHIN MEDICAL, INC. THE DEVICE WAS MFR IN OCTOBER 1989 BY CD MEDICAL, INC. ALTHIN MEDICAL PURCHASED THE MFG FACILITY IN 1990.

    Description of Event or Problem · 1

    FACILITY ALLEGES THAT THE BYPASS VALVE FAILED ON THE MACHINE, AND THAT THE PT WAS "ESTIMATED" TO HAVE HAD TWO OR THREE TREATMENTS WITH NO DIALYSATE GOING TO THE DIALYZER. THE FACILITY REPORTED THAT NEITHER THE PT NOR THE STAFF NOTICED THERE WAS NO FLOW TO THE DIALYZER, EVEN THOUGH THE FLOW INDICATOR SHOWED THERE WAS NO FLOW. THE FACILITY REPORTED THAT BLOOD TEST RESULTS BEFORE FOUR TREATMENTS IN A ROW CAME BACK WITH ELEVEATED POTASSIUM AND/OR ELEVATED CREATININE AND BUN LEVELS. THE FACILITY ALLEGES THAT THE PT DIED IN THE HOSPITAL WHILE HE WAS BEING TREATED TO LOWER HIS BLOOD ELECTROLYTES. THE FACILITY ALLEGES THAT THE AUTOPSY REPORT LISTED MYOCARDIAL INFECTION, SEVERE AORTIC ARTHEROSLEROSIS WITH ULCERATION AND CALCIFICATION, AND CORONARY ATHEROSCLEROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAKE WILLOCK HEMODIALYSIS MACHINE FKP ALTHIN MEDICAL, INC. 480 HIGH FLOW UF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death ALTHIN BLOOD LINES,| EXCEL 15 GAUGE NEEDLES.| TORRAY B122 DIALYZER,