BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 1052105 · Received May 12, 2008

    Report

    Report Number
    1052105
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    August 3, 2007
    Report Date
    May 7, 2008
    Manufacturer
    GAMBRO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DIALYSIS MACHINE WAS NOT PRIMING THE BICARBONATE. BIOMED FOUND THAT THE BICARBONATE CONNECTOR WAS NOT FULLY INSERTED INTO THE ORANGE PORT. THE USER HAD NOT PROPERLY SEATED THE CONNECTOR INTO THE PORT AND THIS CAUSED THE MACHINE NOT TO PRIME THE BLOOD CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS MACHINE FII GAMBRO C-3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR