BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYTICAL STATION

    MDR report key: 2844183 · Received November 25, 2012

    Report

    Report Number
    1061932-2012-02690
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE HAD OBSERVED THERE WAS AN ISOTON POOLED AROUND THE DIFFERENTIAL (DIFF) MODULE. THE SOURCE OF THE LEAK WAS WORN PINCH VALVE (VL) 46B. THE VL46 SUPPLIES PRESSURIZED DILUENT TO RINSE THE UPPER CHAMBER IN THE FLOW CELL. THE FSE CLEANED AND DRIED THE LIGHT SCATTER PREAMP WHICH HAD GOTTEN LEAKED ON FROM THE WORN TUBING. ONCE DRIED, THE PREAMP WORKED PROPERLY. THE FSE ALSO CLEANED THE REST OF THE FLUID LEAK FROM AROUND THE DIFF TOWER. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED, INSTRUMENT RAN WITHOUT INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THE COULTER LH 750 ANALYTICAL STATION WAS GENERATING LIGHT SCATTER (LS) OFFSET ERRORS AND R FLAGS FOR THE DIFFERENTIALS WHILE THE CUSTOMER WAS RUNNING QC. THE CUSTOMER POWERED THE UNIT OFF/ON AND OBSERVED A LEAK. THE VOLUME OF THE LEAK WAS APPROXIMATELY 1 CUP AND NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THE LAB'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE PROTECTION, AND A LAB COAT AT THE TIME OF THE EVENT. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. FLUIDS ASSOCIATED WITH THIS EVENT WERE DILUENT AND CLENZ. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 ANALYTICAL STATION COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1