BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3180791 · Received June 20, 2013

    Report

    Report Number
    1061932-2013-01127
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 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, US
    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 OBSERVED THAT THE INSTRUMENT WAS LEAKING CLEANER. THE FSE FOUND THE SOURCE OF THE LEAK WAS THE TUBING AT PINCH VALVE (PV 44). THE PV44 CONTROLS THE PRESSURIZED DILUENT FOR FLUSHING THE UPPER PART OF THE FLOWCELL. THE FSE REPLACED THE AFFECTED TUBING AND ALSO REPLACED ALL DILUTER TUBING AND PERFORMED PREVENTIVE MAINTENANCE (PM) AS IT WAS COMING DUE. AFTER SERVICING THE INSTRUMENT, NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE CAUSE OF THE LEAK WAS THE TUBING AT PV44. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK COMING FROM THE RIGHT SIDE OF THE COULTER LH 500 HEMATOLOGY ANALYZER WHILE RUNNING A STARTUP. THE VOLUME OF THE LEAK IS UNKNOWN AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. IT COULD NOT BE DETERMINED IF THE INSTRUMENT GENERATED ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. 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, EYE PROTECTION, AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. 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
    281496 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1