BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3183394 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01142
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT THE WBC (WHITE BLOOD CELL) BATH (VC3) HAD BECOME DETACHED FROM THE WBC APERTURES. THE FSE REPLACED THE APERTURE O-RINGS AND SECURED THE BATH TO THE APERTURES TO RESOLVE THE LEAK. RESULTS: FAILURE MODE IS ATTRIBUTED TO THE DETACHED WBC BATH (VC3) FROM THE WBC APERTURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A GREEN COLORED FLUID LEAK OF APPROXIMATELY 10 - 20 ML BELOW THE LEFT SIDE OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND FLUID LEAKED ONTO THE FLOOR. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283902 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1