BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER

    MDR report key: 2786527 · Received October 12, 2012

    Report

    Report Number
    1061932-2012-02538
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE COULTER HMX HEMATOLOGY ANALYZER LEAKED APPROXIMATELY 1ML OF CLEAR LIQUID AT THE BLOOD SAMPLING VALVE (BSV) ONTO THE COUNTER. THE CUSTOMER WAS WEARING GLOVES, A LAB COAT, AND GOGGLES AT THE TIME OF THE OCCURRENCE. THERE WAS NO INJURY OR EXPOSURE TO MUCOUS MEMBRANE OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO PATIENT RESULTS WERE AFFECTED. THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAK AT THE BSV. THE FSE NOTICED THAT THE FRONT BLOOD DETECTOR WAS LOOSE AND WAS OBSTRUCTING THE PROBE WIPE FROM MAKING A COMPLETE MOVEMENT. THE FSE READJUSTED THE BLOOD DETECTOR AND THE PROBE WIPE AND THE LEAK WAS FIXED. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTO LOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1