BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1163283 · Received September 18, 2008

    Report

    Report Number
    2087532-2008-00098
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ADULT FEMALE PT EXPIRED ABOUT 1 1/2 HRS INTO THEIR HEMODIALYSIS TREATMENT. A GAMBRO SVC TECH INSPECTED THE MACHINE PRIOR TO ITS RETURN TO CLINICAL USE. IT IS THE DCI CORPORATE POLICY THAT NO OTHER INFO ABOUT THE PT OR THE TREATMENT WILL BE DISCLOSED.

    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