BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2352113 · Received November 29, 2011

    Report

    Report Number
    1061932-2011-02477
    Event Type
    Malfunction
    Date Received
    November 29, 2011
    Date of Event
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK INSIDE THE BACK OF THE COULTER HMX ANALYZER WITH AUTOLOADER. (HMX AUTOLOADER). CUSTOMER REPORTED THAT THERE WAS A CLEAR FLUID UNDER THE HMX AUTOLOADER. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) DID NOT OBSERVE ANY LEAK AND WAS UNABLE TO REPLICATE THE PROBLEM. TO PREVENT ANY POSSIBLE ISSUE THE FSE MOVED THE REAR BLOOD DETECTOR UP AND OUT OF THE WAY OF BLOOD SAMPLE VALVE (BSV) REAR TUBING, ROUTED THE DIFFERENTIAL AIR LINE AT THE BSV AWAY FROM THE REAR DETECTOR AND PERFORMED PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1