BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1317918 · Received December 23, 2008

    Report

    Report Number
    2087532-2008-00100
    Event Type
    Other
    Date Received
    December 23, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    GAMBRO RECEIVED A REPORT THAT DURING A HEAT CITRIC DISINFECTION PROCEDURE, THE BICARBONATE CONCENTRATE TUBING CAME OFF THE BLUE MALE CONCENTRATE CONNECTOR ASSEMBLY ON THE LOWER FRONT PANEL OF A PHOENIX MACHINE. FOLLOWING THIS DISCONNECTION, A NURSE WAS BURNED BY HOT WATER THAT SPRAYED ONTO HER LEG. THE NURSE WAS TREATED ACCORDING TO THE UNIT'S POLICY (SHE WAS NOT TREATED IN THE EMERGENCY ROOM OR SEEN BY A PHYSICIAN). THE NURSE RETURNED TO WORK THE FOLLOWING DAY. THE PHOENIX MACHINE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX HEMODIALYSIS EQUIPMENT FII GAMBRO DASCO PHOENIX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other