BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3831576 · Received May 25, 2014

    Report

    Report Number
    1061932-2014-01165
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND A LEAK THROUGH TUBING AT PINCH VALVE PV37. THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK UNDERNEATH THE LH500 INSTRUMENT. THE CUSTOMER WAS RUNNING A CLEANING CYCLE WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 5 MILLILITERS 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
    309703 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1