BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3780943 · Received April 30, 2014

    Report

    Report Number
    1061932-2014-00950
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED. THE FSE WAS ABLE TO TROUBLESHOOT THE LEAK WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER FOUND THAT THERE WAS SALTY BUILDUP CLOGGING THE RETIC SEGMENT VALVE CVL87/127 AND WAS CAUSING THE LINES TO BECOME DISCONNECTED FROM THE MIXING CHAMBERS. THE FSE INSTRUCTED THE CUSTOMER TO CLEAR THE SHEAR VALVE BY CLEANING AND PRIMING THE VALVE. THE CUSTOMER CLEARED THE CLOGGED VALVE AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. (B)(4). CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE DIFFERENTIAL MIXING CHAMBER OF THE LH750 INSTRUMENT. THE INSTRUMENT WAS FAILING RETIC CONTROLS WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS NOT SPECIFIED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259994 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1