BEUDAMED
    FDA Adverse Event Death Summary report: N

    BAXTER MANUFACTURING COMPANY

    MDR report key: 368737 · Received December 24, 2001

    Report

    Report Number
    MW1023674
    Event Type
    Death
    Date Received
    December 24, 2001
    Report Date
    November 16, 2001
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FKJ
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DIED IN 2001 AFTER USING DIALYSIS FOR ALMOST ONE YEAR. THIS PROCEDURE DID NOT ENHANCE THE PT'S HEALTH - JUST THE OPPOSITE. PT WAS ALWAYS EXHAUSTED AFTERWARD AND WOULD LIE ON THE COUCH IN DEEP SLEEP FOR FOUR TO FIVE HRS AFTER EACH TREATMENT. ON LATER MONTHS, THE ATTENDANTS SAID THE PT HAD DEVELOPED "GERMS IN THE PT'S BLOODSTREAM" AND WAS THEN GIVEN AN ANTIBIOTIC DURING THE DIALYSIS. IT SHOULD BE NOTED THAT THE PT DIED WITHIN APPROX TWO (2) DAYS OF RECEIVING THE LAST DIALYSIS TREATMENT. AFTER THE PT'S DEATH, THE RPTR RETURNED TO THE DIALYSIS CTR AND ASKED IF THEY WERE AWARE THAT THE BAXTER FILTER THEY WERE USING WAS BEING WITHDRAWN WORLDWIDE. THEIR REPLY WAS, "THEY KNOW ALL ABOUT IT. THEY HAVE STOPPED USING THE FILTER AND HAVE RETURNED ALL OF THEIR SUPPLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58383 BAXTER MANUFACTURING COMPANY DIALYSIS BLOOD FILTER FKJ BAXTER HEALTHCARE CORP UNK AT THIS TIME *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death