BEUDAMED
    FDA Adverse Event Death Summary report: N

    REVACLEAR DIALYZER

    MDR report key: 3212721 · Received July 1, 2013

    Report

    Report Number
    MW5030783
    Event Type
    Death
    Date Received
    July 1, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    GAMBRO
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) WOMAN, PRESENTED TO DIALYSIS WITH LETHARGY AND WEAKNESS. PROBLEMS ENCOUNTERED INITIALLY WITH FISTULA CANNULATION BUT RESOLVED AND OTHERWISE UNEVENTFUL DIALYSIS. PT MORE WEAK AT THE END OF DIALYSIS. SENT TO ER AT 0940 ON (B)(6) 2013 AND BLOOD DRAW SUGGESTED MASSIVE HEMOLYSIS. HGB = 2.9. SPUN HCT = 10%. PLASMA BURGUNDY IN COLOR. BLEEDING FROM AV FISTULA IN RIGHT ARM. LAST KNOWN HEMOGLOBIN WAS 11.3 ON (B)(6) 2013. PT DEVELOPED DIC LIKE EPISODE. POTASSIUM 5.8 AND LACTIC ACID = 5.3 MMOL/LITER. PT HAD TEMPORARY HEMODIALYSIS CATHETER PLACED AND EMERGENT DIALYSIS WAS CARRIED OUT. SHE WAS TRANSFUSED WITH 8 UNITS OF PRBC'S AND 10 UNITS OF FFP PLUS ONE UNIT OF CRYOPRECIPITATE. HEMOGLOBIN STABILIZED AT 12-13 GRAMS PER DL POST DIALYSIS. LIVER FAILURE ENSUED WITH REFRACTORY HYPOGLYCEMIA AND PROGRESSIVE LACTIC ACIDOSIS WITH PH=6.99. PT EXPIRED WHEN FAMILY ELECTED COMFORT CARE. DIALYSIS WAS WITH COBE PHOENIX DIALYSIS MACHINE AND BAXTER REVACLEER DIALYZER AND TUBING INSPECTED BUT NO DEFECTS SEEN. RUN SHEETS SHOW NO ABNORMAL PRESSURES. DIALYZER AND TUBING WITH CASSETTE HAS BEEN SAVED AND REFRIGERATED. AUTOPSY DENIED. PT HAS BEEN ON TH. DIAGNOSIS OR REASON FOR USE: END STAGE RENAL DISEASE. PT HAS BEEN ON THRICE WEEKLY DIALYSIS SINCE (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297830 REVACLEAR DIALYZER DIALYSIS FILTER KDI GAMBRO C413113601
    297831 COBE HEMODIALYSIS MACHINE KDI GAMBRO
    297832 PHOENIX DIALYSIS MACHINE CARTRIDGE & TUBING FJK GAMBRO

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death