BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2798239 · Received October 22, 2012

    Report

    Report Number
    1061932-2012-02568
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND FOUND THE LEAK UNDER THE INSTRUMENT WAS CAUSED BY A BROKEN PROBE WIPE WASH TRUCK. ALTHOUGH A PROBE WASH TRUCK MAY CONTAIN BLOOD AND DILUENT WHILE IN OPERATION AND CLEANER WHILE IN SHUTDOWN; THIS PARTICULAR LEAK ONLY CONTAINED DILUENT. THE FSE REPLACED THE PROBE WIPE WASH TRUCK TO RESOLVE THE ISSUE. FAILURE MODE OF THE EVENT WAS THE BROKEN PROBE WIPE WASH TRUCK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED 100 ML YELLOWISH FLUID LEAK UNDER THE FRONT CENTER AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED, NO DEATH, INJURY OR EXPOSURE WAS REPORTED. PATIENT RESULTS WERE NOT AFFECTED BY THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE A RISK MANAGEMENT/EXPOSURE CONTROL PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1