BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX

    MDR report key: 725882 · Received May 10, 2006

    Report

    Report Number
    9616240-2006-00337
    Event Type
    Malfunction
    Date Received
    May 10, 2006
    Report Date
    May 10, 2006
    Manufacturer
    GAMBRO DASCO
    Product Code
    FII
    PMA / PMN Number
    K001156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY WAS REPORTED. THIS IS THE SECOND TIME THAT THE PROBLEM OCCURRED WITH HE SAME PATIENT ON THE SAME MACHINE (REFERRED TO MDR 9616240-2006-0036. A GAMBRO TECHNICIAN INSPECTED THE MACHINE. HE REPLACED THE PRESSURE TRANSDUCER AND THE MAIN BOARD. INVESTIGATION IS ONGOING. 510(K)# IS K001156

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOOD LOSS FOLLOWING A HIGH VENOUS PRESSURE ALARM. VENOUS PRESSURE WENT UP VERY HIGH, OVER 900 MMHG AFTER 5 TO 10 MINUTES OF TREATMENT. THE MACHINE ALARMED WITH A BLOOD LEAK CONDITION. AN OVERRIDE OF THE ALARM WAS PERFORMED. VENOUS PRESSURE WENT HIGH AGAIN AND A NEW BLOOD LEAK ALARM WAS TRIGGERED. BLOOD RESTITUTION WAS INITIATED AND RINSING WAS PERFORMED. THE BLOOD TUBING SET AND DIALYZER WERE REPLACED. MACHINE BLOCKED AND IT WAS SWITCHED OFF AND ON AGAIN. SETUP WAS RE-INITIATED.

    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