BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3200441 · Received July 1, 2013

    Report

    Report Number
    1061932-2013-01244
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED THAT THE SOURCE OF THE LEAK WAS A CUT TUBING AT PINCH VALVE (PV) 43. THE FSE REPLACED THE AFFECTED TUBING, RESOLVING THE LEAK. THE CAUSE OF THE LEAK WAS A CUT TUBING AT PV43. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK UNDER THE COULTER LH 500 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK IS UNKNOWN AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. IT COULD NOT BE CONFIRMED IF THE INSTRUMENT GENERATED ANY ERROR MESSAGES OR FLAGS IN RELATION TO THIS INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298834 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1