BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOENIX

    MDR report key: 1031544 · Received March 31, 2008

    Report

    Report Number
    2087532-2008-00031
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GAMBRO DASCO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    GAMBRO RECEIVED A COMPLAINT ON FEB 26, 2008 FROM A FACILITY WHO REPORTED THAT A PHOENIX MACHINE WAS LEAKING AND WENT INTO GENERAL SAFE STATE. IT WAS UNK WHEN THE LEAK OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION WARRANTED IN THIS EVENT. NO EVIDENCE THAT A TUBE DISCONNECTION RELATED ALARM OCCURRED. A GAMBRO TECH INSPECTED THE MACHINE AND FOUND THE SILICONE ELBOW DISCONNECTED FROM PO TRANSDUCER. HE RECONNECTED THE SILICONE ELBOW TO THE PO TRANSDUCER. HE PERFORMED AN ADR RINSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other