BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMA SET

    MDR report key: 1739611 · Received June 24, 2010

    Report

    Report Number
    8010182-2010-00001
    Event Type
    Death
    Date Received
    June 24, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 2, 2010
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K032431
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT HAS NOT BEEN COMPLETED. THE EXTRACORPOREAL SET WAS DISCARDED AND NOT AVAILABLE FOR INSPECTION. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A CRITICALLY ILL PT WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PRISMA MACHINE AT A CLINIC IN (B) (6). THE CUSTOMER REPORTED THE PRISMA GENERATED NUMEROUS ALARMS INCLUDING "CAUTION PRESSURE IN RETURN LINE TOO HIGH" AND IT WAS NOTED THE TRANSMEMBRANE PRESSURE INCREASED TO 650 MMHG. THE NURSE OBSERVED AN EXTERNAL BLOOD LEAK FROM THE EXTRACORPOREAL CIRCUIT AT THE SAME TIME SHE OBSERVED THE EFFLUENT FLUID WAS PINK TINGED AND THE PRISMA DID NOT GENERATE THE BLOOD LEAK DETECTOR ALARM. THE PRISMA MACHINE WAS INSPECTED AND FOUND TO BE OPERATING WITHIN MFR'S SPEC. THE EXTRACORPOREAL SET WAS DISCARDED AND NOT AVAILABLE FOR ANALYSIS. THE EFFLUENT FLUID WAS NOT TESTED BY THE CLINIC FOR THE PRESENCE OF RED BLOOD CELLS BEFORE THE SET WAS DISCARDED. DURING THE INVESTIGATION OF THIS EVENT, THE CUSTOMER REPORTED THE PT EXPIRED DURING TREATMENT. AT THIS TIME THERE IS NO CLINICAL INFO SURROUNDING THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA SET PRISMA M100 PRE PUMP KDI GAMBRO INDUSTRIES M100 PRE PUMP 10B0253G

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death PRISMA: (B) (4)