BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA SYSTEM

    MDR report key: 293251 · Received August 30, 2000

    Report

    Report Number
    1724819-2000-00001
    Event Type
    Death
    Date Received
    August 30, 2000
    Date of Event
    August 7, 2000
    Report Date
    August 9, 2000
    Manufacturer
    GAMBRO DASCO S.P.A.-EQUIPMENT DIV.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH DIABETES ADMITTED TO THE ICU. ON 08/05/2000 PT WAS HEMODIALYZED FOR ONE HOUR ON A ZERO POTASSIUM BATH BECAUSE OF 7.2 SERUM POTASSIUM. POST DIALYSIS POTASSIUM WAS 5.8, WHICH WAS DRAWN IMMEDIATELY AFTER DIALYSIS. THE DECISION WAS MADE TO INITIATE CONTINUOUS RENAL REPLACEMENT THERAPY. PT WAS ON ANTIBIOTICS BUT THERE WAS NO DIAGNOSIS OF SEPSIS. THE DECISION WAS MADE TO INITIATE A CVVHD TREATMENT AT ABOUT 8 P.M. PT WAS INTUBATED SHORTLY AFTER THE TREATMENT WAS INITIATED AND REQUIRED A CHEST X-RAY FOR TUBE PLACEMENT. AT APPROX 3:00 A.M. ON 08/07/2000, AN X-RAY TECHNICIAN ACCIDENTALLY TURNED OFF THE PRISMA MACHINE WHILE PLACING A POSTERIOR PLATE. AFTER THE CLINICIAN/S TURNED THE PRISMA BACK ON, THEY DID NOT FOLLOW THE ON SCREEN INSTRUCTIONS OR INSTRUCTIONS IN THE OPERATOR'S MANUAL TO CONTINUE THE TREATMENT OR DISCONNECT THE PT (CHAPTER 6. PRISMA SYSTEMS OPERATOR'S MANUAL). THE CORRECT SEQUENCE WOULD HAVE BEEN TO PRESS CONTINUE, SINCE THEY DID NOT WANT TO START A NEW TREATMENT. IT WAS RELATED BY THE DIALYSIS NURSE THE EVENT INFO SCREEN ON THE PRISMA SHOWED THE CLINICIAN/S SELECTED END TREATMENT, UNLOAD, RESTART, SAME PT, LOAD SET, AND PRIME. IN THE PRIME MODE THE PRISMA BLOOD-PUMP TURNS IN THE OPPOSITE DIRECTION. THE CLINICIAN/S ATTEMPTED TO MANUALLY TURN THE BLOOD-PUMP IN THE OTHER DIRECTION, CAUSING A MALFUNCTION BLOOD PUMP ALARM. BLOOD BACKED INTO THE ADMINISTRATION SET THAT WAS ATTACHED TO A STOPCOCK FOR SALINE RINSING OF THE FILTER. THE NURSE RELATED THE PT'S CATHETER LINES WERE CLAMPED, BUT PT WAS NOT DISCONNECTED FROM THE MACHINE. THE HIGH PRESSURE IN THE ADMINISTRATION SET CAUSED THE ADMINISTRATION SET TO RUPTURE AT THE INJECTION SITE. THE NURSE RELATED THE PT LOST THE AMOUNT OF BLOOD IN THE EXTRACORPOREAL CIRCUIT (90ML +/- 10ML). WHILE THE NURSES WERE ATTEMPTING TO CORRECT THE PRISMA PROBLEMS, THE PT DEVELOPED AN ARRHYTHMIA FOLLOWED BY VENTRICULAR TACHYCARDIA AND EXPIRED. THE DIALYSIS NURSE THAT INITIATED THE CALL ALSO VIEWED THE EVENT INFO SCREEN AND RELATED THE CLINICIAN/S INABILITY TO MANAGE THE PRISMA CORRECTLY WAS THE REASON THE PT LOST THE BLOOD VOLUME IN THE EXTRACORPOREAL CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA SYSTEM FLUID MANAGEMENT SYSTEM FII GAMBRO DASCO S.P.A.-EQUIPMENT DIV. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death