BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELFOAM ABSORBABLE GELATIN

    MDR report key: 563332 · Received December 28, 2004

    Report

    Report Number
    1810189-2004-00012
    Event Type
    Death
    Date Received
    December 28, 2004
    Report Date
    December 21, 2004
    Manufacturer
    *
    Product Code
    LFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WITH HYPERTENSION AND DIABETES MELLITUS HAD BEEN TREATED IN THE PAST FOR HEPATOCELLULAR CARCINOMA BUT HAD BEEN POORLY CONTROLLED. THE PT COMPLAINT OF RIGHT ABDOMINAL PAIN AND WAS REFERRED TO THE HOSP. ABDOMINAL CT (COMPUTERIZED TOMOGRAM) AND ULTRASOUND EXAMINATION ON ADMISSION DEMONSTRATED A TUMOR WITH ILL-DEFINED MARGINS, 7 CM AND MORE OF THE LONG AXIS, IN THE RIGHT HEPATIC LOBE, A TUMOR EMBOLUS IN THE RIGHT PORTAL VEIN AND SMALL AMOUNTS OF PLEURAL EFFUSION AND ASCITES. SIMILARLY, ABDOMINAL ANGIOGRAM REVEALED DIFFUSE MULTIFOCAL CARCINOMA HEPATOCELLULAR WITH A TUMOR EMBOLUS OF THE PORTAL VEIN IN THE RIGHT HEPATIC LOBE. HEPATIC ARTERIOGRAM SHOWED A MARKED AP (ARTERIO-PORTAL) SHUNT IN THE RIGHT HEPATIC LOBE AND WELL-CONTRASTED LEFT PORTAL VEIN. AP SHUNT WAS SELECTIVELY EMBOLIZED WITH GELFOAM (GELATIN) AND FARMORUBICIN (EPIRUBICIN HYDROCHLORIDE) 30 MG, AND FARMORUBICIN 10 MG AND LIPIODOL ULTRA FLUIDE (ETHYL ESTER OF IODINATED POPPY-SEED OIL FATTY ACID) WERE INTRA-ARTERIALLY ADMINISTERED. ON DAY 2 AFTER SURGERY, PYREXIA OF 40.1 DEGREES C AND CONSCIOUSNESS CLOUDING WERE OBSERVED. VENOUS BLOOD CULTURE ON DAY 4 AFTER SURGERY REVEALED SALMONELLA AT 0 TO 7. TREATMENT WITH BIAPENEM 0.6 G/DAY WAS STARTED. THE FEVER DECLINED QUICKLY, AND THEIR CONDITION OF CONSCIOUSNESS ALSO IMPROVED. HOWEVER, ON DAY 11 AFTER SURGERY, THEY DEVELOPED FEVER OF 38.9 DEGREES C AGAIN. VENOUS BLOOD CULTURE SHOWED SALMONELLA AT 0 TO 7. TREATMENT WITH CIPROFLOXACIN HYDROCHLORIDE 600 MG/DAY WAS STARTED. ABDOMINAL CT DISCLOSED ABSCESS AFTER HEPATIC TUMOR EMBOLIZATION. A PERCUTANEOUS TRANSHAPATIC DRAINAGE OF A TUMOR WAS PERFORMED. A TEST WITH THE DRAINAGE FLUID COLLECTED FROM THIS DRAINAGE AND SUBSEQUENT BLOOD CULTURE DID NOT REVEAL SALMONELLA OF 0 TO 7. HOWEVER, DETERMINATIONS WITH PLEURAL EFFUSION AND ASCITES, WHICH WERE CAUSED BY HEPATIC FAILURE, ON DAY 39 AFTER SURGERY, SHOWED SALMONELLA AT 0 TO 7. THE PT DIED OF HEPATORENAL FAILURE ON DAY 43 AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM ABSORBABLE GELATIN POWDER, STERILE LFM * UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death