BEUDAMED
    FDA Adverse Event Summary report: N

    PRISMA M60 PRE SET

    MDR report key: 3131298 · Received April 9, 2006

    Report

    Report Number
    2087532-2006-00107
    Date Received
    April 9, 2006
    Date of Event
    August 2, 2006
    Report Date
    August 31, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PER FAX - CUSTOMER STATED THAT SHE WAS UNLOADING HER MACHINE AND THE BOTTOM ACCESS POD EXPLODED. CUSTOMER SAID THE MACHINE FAILED A SELF TEST OF AIR IN THE SYSTEM. WHEN CUSTOMER WAS REMOVING IT. TOWARDS THE END OF TREATMENT - 48 HR MARK) SHE THOUGHT HER MACHINE CLOTTED, BUT THE PRISMA DID NOT ALERT HER THAT IT WAS CLOTTED, SO CUSTOMER REMOVED THE SET AND ACCESS POD EXPLODED. THE HIGHEST FILTER PRESSURE THAT THE CUSTOMER HAD ON THE MACHINE WAS 220. PER LINDA DRESSER (IC THERAPY SPECIALIST), INFORMED CUSTOMER THAT WAS NOT THE NORMAL FILTER PRESSURES, 220 WAS TOO HIGH. NO PATIENT INJURY - NO MEDICAL INTERVENTION, PATIENT IS OK. SAMPLE IS AVAILABLE. MFR - 8010182-2006-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA M60 PRE SET PRISMA M60 PRESET KDI GAMBRO INDUSTRIES M 60 PRESET 06C2279P

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other