BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3191878 · Received June 27, 2013

    Report

    Report Number
    1061932-2013-01206
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT THE AIR LEAK WAS DUE TO A DISCONNECTED TUBING AT A 5-WAY (FLIPPER RETRACT) SOLENOID FOR THE RIGHT LIFT. THE FSE TRIMMED THE END OF THE TUBING AND RESEATED THE TUBING ONTO THE FITTING TO RESOLVE THE AIR LEAK ISSUE. THE FSE INDICATED THAT THE FLUID LEAK WAS ASSOCIATED WITH A GREEN STRIPE TUBING AT THE SHEATH FLOW COIL AT THE UPPER RIGHT PANEL OF THE DILUTER. THE FSE REPLACED THE GREEN STRIPE TUBING TO RESOLVE THE LEAK AND REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE AIR LEAK IS ATTRIBUTED TO A DISCONNECTED TUBING AT THE FLIPPER RETRACT SOLENOID FOR THE RIGHT LIFT. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A GREEN STRIPED TUBING AT THE SHEATH FLOW COIL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK OF APPROXIMATELY 1 ML FROM THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE TROUBLESHOOTING AN AIR LEAK. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND THE INSTRUMENT DID NOT GENERATE ERROR MESSAGES FOR THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT 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
    294773 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1