BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMA TPE SET

    MDR report key: 3041516 · Received April 8, 2013

    Report

    Report Number
    8010182-2013-00002
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    LKN
    PMA / PMN Number
    P830063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILTER SET WAS DISCARDED AND THEREFORE, NOT AVAILABLE FOR INSPECTION. THE REVIEW OF THE DEVICE HISTORY RECORD OF THIS LOT AND THE COMPLAINT HISTORY FILES HAS SHOWN THAT THERE WERE NO NONCONFORMITIES AND NO OTHER COMPLAINT REPORTED ON THIS LOT.

    Description of Event or Problem · 1

    A PATIENT IN THE (B)(6) WAS UNDERGOING THERAPEUTIC PLASMA EXCHANGE (TPE) TREATMENT. APPROXIMATELY 10 MINUTES INTO THE TREATMENT THE PRISMA MACHINE GENERATED SEVERAL "AIR IN SET" ALARMS AND AIR WAS OBSERVED INSIDE THE PLASMA FILTER. THE TREATMENT WAS DISCONTINUED AND THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE ESTIMATED BLOOD LOSS TO THE PATIENT WAS 200 ML. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE BLOOD LOSS HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS TRANSFUSED WITH A UNIT OF BLOOD THAT EVENING. THERE WAS NO FURTHER MEDICAL OR LABORATORY DATA PROVIDED. THE PRISMA MACHINE GENERATED SEVERAL "AIR IN SET" ALARMS, WHICH IS IN ACCORDANCE WITH SPECIFICATIONS. NO MACHINE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143186 PRISMA TPE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN GAMBRO INDUSTRIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PRISMA, SN UNKNOWN