BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER

    MDR report key: 237923 · Received August 26, 1999

    Report

    Report Number
    MW1017066
    Event Type
    Death
    Date Received
    August 26, 1999
    Date of Event
    July 26, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP. RENAL DIV.
    Product Code
    FKP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D 9/2/99: THIS 60 YO WHITE FEMALE, AS THE DEATH SUMMARY INDICATES, WAS SHOWING EVIDENCE OF SEVERE HEMOLYSIS. THIS WAS ON THE BLOOD SAMPLE DRAWN WITHIN 15 MINS OF DISCONTINUING DIALYSIS. REPEAT SAMPLING OVER THE NEXT COUPLE OF HRS ALSO SHOWED EVIDENCE OF INTENSE HEMOLYSIS. SUBSEQUENTLY, IT WAS CONFIRMED THAT HER PLASMA FREE HEMOGLOBIN LEVEL WAS MARKEDLY ELEVATED. HER SERUM LDH WAS ALSO VERY HIGH AND HER BLOOD HEMOGLOBIN VALUE HAD DROPPED FROM 11.5 DOWN TO AROUND 9 GRAMS DURING THIS EPISODE. MEANWHILE, THE SERUM HAPTOGLOBIN WAS MARKEDLY DECREASED. THE COOMB'S TEST WAS NEGATIVE AND ANTIBODY SCREEN WAS NEGATIVE. AS SUCH, USER FELT THAT THE PT INDEED WAS HAVING ACUTE HEMOLYSIS. BECAUSE OF THE TEMPORAL RELATIONSHIP, OF COURSE DIALYSIS INDUCED HEMOLYSIS CANNOT BE EXCLUDED. ON THE AUTOPSY THE PT HAD MARKED CARDIOMEGALY AND SEVERE CORONARY ARTHEROSCLEROTIC HEART DISEASE, SO THAT COULD HAVE PLAYED A MAJOR ROLE IN HER DEMISE (CORONARY ISCHEMIA). WITH THE HEMOLYSIS SHE ALSO DEVELOPED SEVERE HYPERKALEMIA WHICH WOULD BE EXPECTED WITH MASSIVE BREAKDOWN OF HER RED BLOOD CORPUSCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER DIALYZER FKP BAXTER HEALTHCARE CORP. RENAL DIV. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death 3) DIALYZER WERE FOUND TO BE FREE OF DEFECTS AND| 2) BLOOD LINES| WITHIN PARAMETER LIMITS.| 1) DIALYSIS MACHINE