BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMBRO

    MDR report key: 1040305 · Received May 7, 2008

    Report

    Report Number
    MW5006757
    Event Type
    Death
    Date Received
    May 7, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GAMBRO
    Product Code
    FJK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CBC DRAW PRE-DIALYSIS IN 2008. PATIENT DIALYZED 3.0 HR ON 2K 2.5 CA DIALYSATE GOAL WAS TO BE 4.5KG. AT 14:15 PATIENT BEGAN CRAMPING AND FEELING SICK TO STOMACH. TREATMENT TERMINATED. PHYSICIAN HERE TO SEE PATIENT. PATIENT SENT TO E.R. DUE TO COUGHING UP GREEN SPUTUM. IN E.R. ABDOMINAL CRAMPING CONTINUED. LAB WORK DRAWN. ADMITTED TO ICU ON THE NEXT DAY, PATIENT DIAGNOSED WITH HEMOLYSIS AND TRANSFUSED WITH THREE UNITS OF PACKED CELLS. ON APPROX THREE MONTHS EARLIER, PATIENT RESPIRATORY STATUS POOR. PT DNR THREE DAYS AFTER THE ORIGINAL DATE. FAMILY DECIDED TO TRANSFER PATIENT TO HOSPICE. ON TWO DAYS LATER, PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO BLOODLINE FJK GAMBRO 003-410-510 03P158227

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death ROCKWELL DIALYSATE| NIPRO SAFETY TOUCH 2 FISTULA NEEDLES| BAXTER EXELTRA 150 DIALYZER LOT# 07J25E| GAMBRO PHOENIX DIALYSIS MACHINE