BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3021465 · Received March 26, 2013

    Report

    Report Number
    1061932-2013-00411
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND LATRON PRIMER VERY HIGH ON RETICS AND ALSO FOUND RED BLOOD CELLS (RBC) AND PLATELETS (PLT) BACKGROUNDS HIGH. FSE DISCOVERED THAT THE SECONDARY ASPIRATION PROBE WAS BENT FROM THE FRONT OF THE UNIT, WHICH CAUSED THE BLOOD SAMPLING VALVE (BSV) TO MISALIGN DURING PROBE WASH. THE MISALIGNMENT CAUSED IMPROPER ASPIRATION OF LATRON PRIMER AND IMPROPER DELIVERY OF RBC DILUENT DURING STARTUP THAT CAUSED THE HIGH LATRON PRIMER AND THE HIGH RBC AND PLT BACKGROUNDS. THE BENT PROBE ALSO CAUSED A MISALIGNMENT OF THE FRONT SECTION OF THE BSV DURING PROBE WASH, WHICH CAUSED A BACK PRESSURE IN THE PROBE RINSE LINE AND A LEAK OF THE PROBE AFTER PROBE WASH. FSE STRAIGHTENED THE BENT PROBE WHICH RESOLVED THE LEAK AND BROUGHT LATRON PRIMER, RBC AND PLT BACKGROUNDS BACK IN SPECIFICATIONS WITH NO ADDITIONAL FLOW CELL CLOG MESSAGES, BECAUSE ADEQUATE SAMPLE WAS ABLE TO REACH THE FLOW CELL FOR ANALYSIS. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE BENT SECONDARY ASPIRATION PROBE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT THE SECONDARY PROBE WASH TRUCK OF A COULTER LH 500 HEMATOLOGY ANALYZER WAS LEAKING. THE RETIC SCATTER WAS LOW ON LATRON AND CUSTOMER WAS GETTING CLOGGED FLOW CELL MESSAGES. THE VOLUME OF THE LEAK WAS NOT SPECIFIED. THE LEAK WAS CONTAINED WITHIN THE UNIT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABCOAT, GLOVES AND GLASSES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123109 COULTER® LH 500 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1