BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3130912 · Received May 24, 2013

    Report

    Report Number
    1061932-2013-00869
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND CONFIRMED A DILUENT LEAK FROM A CUT ON THE SHEATH RESTRICTOR TUBING AT PINCH VALVE VL46B. THE FSE DETERMINED THAT THE TUBE WAS DAMAGED BY CONTINUOUS ROTATING MOTION AT ONE OF THE FITTINGS ON THE DIFFERENTIAL MIXING CHAMBER. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK AND THE VOLTAGE/PRESSURE ERRORS AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE IS ATTRIBUTED TO A CUT ON TUBING AT PINCH VALVE VL46B. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK OF APPROXIMATELY 3 ML FROM THE COULTER LH 780 HEMATOLOGY ANALYZER AND THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. A REVIEW OF THE INSTRUMENT'S ERROR LOG INDICATES THAT THE INSTRUMENT GENERATED MULTIPLE "FLOWCELL VOLTAGE ERRORS/PRESSURE OUT OF SPECIFICATION" AT THE TIME OF THE EVENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND GOGGLES 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
    231157 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1