BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3103477 · Received May 9, 2013

    Report

    Report Number
    1061932-2013-00756
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND CONFIRMED A LEAK FROM A SMALL PINHOLE IN TUBING AT PINCH VALVE PV61. THE FSE REPLACED THE TUBING THROUGH PV61 TO RESOLVE THE LEAK. THE FSE INDICATED THAT THE LEAK WET THE PELTIER CONNECTION CAUSING PELTIER ERRORS TO BE GENERATED. THE FSE CLEANED AND DRIED THE PELTIER ASSEMBLY TO RESOLVE THE PELTIER ERRORS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A SMALL PINHOLE IN TUBING AT PV61 WHICH IN TURN WET THE PELTIER CONNECTION CAUSING THE PELTIER ERRORS TO BE GENERATED. THE INSTRUMENT GENERATED PELTIER ERRORS ALERTING THE CUSTOMER TO AN INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEANER LEAK OF APPROXIMATELY 20 - 30 ML INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER DURING INSTRUMENT SHUTDOWN. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THE INSTRUMENT GENERATED PELTIER ERRORS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS 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
    204164 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1