BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA CONTROL UNIT 018080101

    MDR report key: 296954 · Received September 21, 2000

    Report

    Report Number
    1724819-2000-00003
    Event Type
    Death
    Date Received
    September 21, 2000
    Date of Event
    August 24, 2000
    Report Date
    September 21, 2000
    Manufacturer
    GAMBRO DASCO S.P.A./EQUIPMENT DIV.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RELATED THE MACHINE HAD A FILTER CLOGGING ALARM AND AN ACCESS EXTREMELY NEGATIVE ALARM. CUSTOMER RELATED THE FILTER WAS CHANGED BECAUSE OF THE CLOGGING ALARM. CUSTOMER RELATED THE PT HAD POTASSIUM OF 6.8 UPON THE INITIATION OF THE TREATMENT. CUSTOMER RELATED OVER THE FIRST 24 HOURS THE SERUM POTASSIUM WAS DECREASING. HOWEVER, AFTER THE FIRST 24 HOURS THE POTASSIUM STARTED TO INCREASE. CUSTOMER RELATED THE PT'S TEMPERATURE WAS ELEVATED AT 103 DEGREES OR 39.4 CELSIUS. IT WAS ALSO RELATED THE PT HAD A PICTURE OF "DIC" (DISSEMINATED INTRAVASCULAR COAGULATION), AND A GASTROINTESTINAL BLEED. THROUGHOUT THE TREATMENT, THE PT'S SYSTOLIC BLOOD PRESSURE WAS BETWEEN 80 AND 90. AT THE TIME OF DEATH, THE PT'S POTASSIUM WAS 6.8. IT WAS RELATED THE PT DIED OF CARDIAC ARREST. IT WAS RELATED THE PHYSICIAN WAS GOING TO PERFORM A HEMODIALYSIS TREATMENT TO DECREASE PT'S POTASSIUM, BUT THE PT EXPIRED BEFORE THE TREATMENT COULD BE INITIATED. CUSTOMER RELATED THE PHYSICIAN FELT THE CAUSE OF DEATH WAS BECAUSE THE PRISMA DID NOT DECREASE THE PT'S POTASSIUM FAST ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA CONTROL UNIT 018080101 CONTINUOUS RENAL REPLACEMENT THERAPY FII GAMBRO DASCO S.P.A./EQUIPMENT DIV. 018080101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death