BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL-PRO

    MDR report key: 238508 · Received August 30, 1999

    Report

    Report Number
    238508
    Event Type
    Death
    Date Received
    August 30, 1999
    Date of Event
    August 2, 1999
    Report Date
    August 2, 1999
    Manufacturer
    NEXELL THERAPEUTICS, INC.
    Product Code
    GKT
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FINAL ANATOMIC DIAGNOSIS: FIFTY-SIX YEAR OLD MALE W/ HX OF AML (TRANSFORMED FROM AGNOGENIC MYELOID METAPLASIA), S/P HLA MATCHED ALLOGENIC BONE MARROW TRANSPLANT 4/99, PRESENTED TO HOSPITAL FOR DIARRHEA, HYPOKALEMIA, AND THROMBOCYTOPENIA. HEMATOPOIETIC SYSTEM: POST-TRANSPLANT BONE MARROW: HYPOCELLULAR W/ MARKEDLY REDUCED MEGAKARYOPOIESIS. LUNGS (RT 950GMS;LT 900GMS): FUNGAL PNEUMONIA ASPERGILLUS SPECIES INVOLVING BOTH LUNGS (PREDOMINANTLY LUL,LLL,RUL,RLL. TRACHEA W/ MULTIPLE ULCERATION AND INVASIVE ASPERGILLUS SPECIES. GI SYSTEM: ASCITES, 600ML, YELLOW SEROUS. STOMACH AND SMALL BOWEL W/ MULTIPLE EROSIONS, MELENA W/IN SMALL AND LARGE BOWEL. PANCREAS: PERIPANCREATIC FAT NECROSIS AND MILD INTERSTITIAL PANCREATITIS. LIVER (2400 GMS). INTRAHEPATIC CHOLESTASIS AND MACROVESICULAR FATTY CHANGE. GU SYSTEM: KIDNEYS (RT 180GMS, LT 164 GMS.) ACUTE TUBULAR NECROSIS, RT KIDNEY SIMPLE, SIMPLE CORTICAL CYST. URINARY BLADDER: MULTIPLE ECCYMOTIC FOCI. TESTIS: (RT 44GM, LT 43GM). ASPERMATOGENESIS (SERTOLI ONLY PATTERN) PROSTATE: BENIGN HYPERTROPHY. HEART: (550 GM). LEFT VENTRICULAR HYPERTROPHY (2CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-PRO CELL SELECTION COLUMN GKT NEXELL THERAPEUTICS, INC. PRECOLUMN, AVIDIN COLUMN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death