BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA PRE SET

    MDR report key: 971306 · Received April 3, 2007

    Report

    Report Number
    2087532-2007-00070
    Event Type
    Other
    Date Received
    April 3, 2007
    Date of Event
    March 3, 2007
    Report Date
    March 5, 2007
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS COMPLAINT CASE FROM ICON. THE REPORTER CALLED TO REPORT THAT ON THE START OF SHIFT FOUND PRISMA CVVHDF WITH BLOOD FLOW OF 180ML/MIN WITH M-100 PRE SET USING HEPARIN AS AN ANTI-COAGULANT, NOTED SOME CLOTS IN THE ACCESS POD AND AT THE TOP OF THE FILTER. ORIGINALLY THE PRESSURES WERE OK, BUT WITH FIRST SELF TEST STARTED GETTING ALTERNATE 0020 AND 00F0 SELF TEST ALARMS. ATTEMPTED NUMEROUS DRF'S ELECTED TO STOP TREATMENT, WHEN DISCONNECTING, NOTE SET ACCESS PRESSURE POD BURST OPEN. RECOMMENDED CUSTOMER DOUBLE BAG SET AND LOT#. SET LOT# 06C0562G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRE SET PRISMA M100 PRE FII GAMBRO INDUSTRIES M100 PRE 06E0562G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other