BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER

    MDR report key: 362070 · Received November 6, 2001

    Report

    Report Number
    MW1023449
    Event Type
    Death
    Date Received
    November 6, 2001
    Date of Event
    October 26, 2001
    Report Date
    November 6, 2001
    Manufacturer
    UNK
    Product Code
    FJI
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS A LONG TERM DIALYSIS PT. AS USUAL PT HAD A MORNING SESSION AT DIALYSIS CTR, WHICH IS PART OF THE HOSP. DURING THAT AFTERNOON THE SAME DAY, PT WAS SENT TO THE HOSP DUE TO VOMITING AND INABILITY TO BREATHE PROPERLY. PT'S ILLNESS LASTED ALL THROUGH THE FOLLOWING DAY, WITH EXTREME HIGH FEVER OF 104 DEGREES. SOMETIME LATER THAT EVENING A TUBE WAS INSERTED DOWN THEIR NOSE INTO STOMACH AND DARK FLUID WAS EXTRACTED. BY THE NEXT DAY PT COULD NOT RESPOND TO TOUCH OR TALK. PT NEVER REGAINED CONSCIOUSNESS AND PASSED AWAY THE NEXT AFTERNOON A LITTLE AFTER 2PM. RPTR WENT TO FIND OUT IF THESE BAXTER INTERNATIONAL INC, MFG DIALYZERS WERE BEING USED AT THE CENTER WHERE PT WAS BEING TREATED. THEY NOTICED THE ARTICLE IN THE PAPER SAID THE FOOD AND DRUG ADMINISTRATION WAS PART OF A TEAM INVESTIGATING THIS MATTER. EVEN THOUGH PT WAS VERY ILL, RPTR WOULD NOT HAVE WANTED THEM CHEATED OUT OF EVEN ONE DAY OF THEIR LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49606 DIALYZER DIALYZER FJI UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death