BEUDAMED
    FDA Adverse Event Death Summary report: N

    TERUMO

    MDR report key: 10472310 · Received August 31, 2020

    Report

    Report Number
    10472310
    Event Type
    Death
    Date Received
    August 31, 2020
    Date of Event
    August 22, 2020
    Report Date
    August 26, 2020
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O MAN WITH A HISTORY OF SIGNIFICANT CORONARY ARTERY DISEASE (STATUS POST PERCUTANEOUS CORONARY INTERVENTION) AND METASTATIC PROSTATE CANCER WAS ADMITTED FOR REPEAT PERCUTANEOUS CORONARY INTERVENTION (B)(6) 2020. ON ADMISSION, HE WAS FOUND TO HAVE SIGNIFICANT THROMBOCYTOPENIA (PLATELET COUNT OF 31 X 1000/UL) THOUGHT TO BE DUE TO THROMBOTIC THROMBOCYTOPENIC PURPURA. HIS TROPONIN LEVELS WERE SLIGHTLY ELEVATED ABOVE THE CUT-OFF VALUE WITHOUT EKG FINDINGS, AND ATTRIBUTED TO A NON-ST-ELEVATION MYOCARDIAL INFARCTION EVENT. HE UNDERWENT SERIAL PLASMAPHERESIS (COMMENCING ON (B)(6) 2020) IN THE HOPE OF REVERSING THE THROMBOCYTOPENIA. HE ALSO DEVELOPED SIGNIFICANT ANEMIA (HEMOGLOBIN 6.3 G/DL) DURING THIS TIME, AND REQUIRED TRANSFUSION WITH TWO UNITS OF PACKED RED BLOOD CELLS. DURING THE FOURTH PLASMAPHERESIS PROCEDURE (B)(6) 2020), HE SUFFERED A CARDIAC ARREST AND WAS FOUND TO HAVE VENTRICULAR TACHYCARDIA PROGRESSING TO PULSELESS ELECTRICAL ACTIVITY. AFTER 20 MINUTES OF RESUSCITATION, NO RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVE. THE PATIENT WAS PRONOUNCED DECEASED AT THAT POINT. THE NEXT OF KIN DECLINED AN AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939266 TERUMO SPECTRA OPTIA APHERESIS SYSTEM GKT TERUMO BCT, INC. 610002

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death