BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1140023 · Received August 20, 2008

    Report

    Report Number
    2087532-2008-00086
    Event Type
    Other
    Date Received
    August 20, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT EXPIRED WHILE DIALYZING ON A PHOENIX MACHINE, SOFTWARE VERSION 3.34. ACCORDING TO THE FACILITY'S CHARGE NURSE, IT IS THE POLICY OF THIS DCI CLINIC NOT TO PROVIDE INFO RELATED TO PT DEATHS AND IT IS ALSO THEIR POLICY TO HAVE THE MACHINE IN USE AT THE TIME OF A PT DEATH REMOVED FROM SVC AND INSPECTED BY THE MFR'S TECHNICAL SVC REP BEFORE IT CAN BE USED AGAIN. A GTS REP INSPECTED THE PHOENIX MACHINE AND FOUND NO PROBLEM WITH THE MACHINE. THE GTS REP. CONCLUDED THAT THE MACHINE WAS OPERATING WITHIN MFR'S SPEC. THE MACHINE WAS RETURNED TO SVC.

    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