BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER

    MDR report key: 3441434 · Received October 31, 2013

    Report

    Report Number
    1061932-2013-02345
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE LEAK WITHIN THE MAIN DILUTER AT PV49; THE INSTRUMENT ALSO GENERATED DIFF R FLAGS. THE FSE REPLACED THE TUBING AT PV49 RESOLVING THE LEAK AND THE DIFF R FLAGS. SERVICE ACTIVITY WAS PERFORMED AND WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. UPON RECUR, THERE IS A POTENTIAL FOR BIOHAZARD EXPOSURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF APPROXIMATELY 5CC¿S OF FLUID IN THE MAIN DILUTER OF THE HMX AUTOLOADER. THE LEAK WAS NOT CONTAINED. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE MSDS WAS NOT REVIEWED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561447 COULTER® HMX HEMATOLOGY ANALYZER W/ AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER HMX AUTOLOADER 115V (198-242/48-62 NA

    Patients

    Seq Age Sex Outcome Treatment
    1