BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1012274 · Received February 6, 2008

    Report

    Report Number
    2087532-2008-00011
    Event Type
    Other
    Date Received
    February 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 8, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    FID
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    GAMBRO REC'D A COMPLAINT ON JANUARY 8, 2008 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING. IT WAS UNK WHEN THE LEAK OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION WARRANTED IN THIS EVENT. NO EVIDENCE THAT A TUBING DISCONNECTION RELATED ALARM OCCURRED. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THAT IT WAS LEAKING AT THE OUTLET OF PO. HE RECONNECTED TUBING AT THE PO. HE PERFORMED A RINSE CYCLE, AND A T1 TEST. HE VERIFIED NO OTHER LEAKS FROM THE MACHINE AND PERFORMED DISINFECTION WITHOUT ANY PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other