BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3130924 · Received May 24, 2013

    Report

    Report Number
    1061932-2013-00870
    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
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ABLE TO ISOLATE THE LEAK TO A DISCONNECTED TUBING AT THE TOP OF THE SHEATH RESTRICTOR PRIOR TO THE BECKMAN COULTER FSE'S (FIELD SERVICE ENGINEER) ARRIVAL. THE CUSTOMER RECONNECTED THE TUBING BACK ON THE FITTING TO RESOLVE THE DILUENT LEAK. THE FSE ARRIVED AT THE CUSTOMER'S SITE AND CONFIRMED THE ASPIRATION ERRORS. THE FSE FOUND THAT A CABLE WAS CORRODED WHICH CAUSED THE DILUTER 3 CARD TO INTERMITTENTLY ENABLE OR DISABLE PINCH VALVE ACTUATOR TO PINCH VALVE VL64. THE FSE REPAIRED THE CABLE AND REPLACED THE DILUTER 3 CARD AS A PREVENTIVE MAINTENANCE TO RESOLVE THE ASPIRATION ERRORS ISSUE. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A DISCONNECTED TUBING FROM THE SHEATH RESTRICTOR AND FAILURE MODE OF THE ASPIRATION ERRORS IS ATTRIBUTED TO A CORRODED CABLE WHICH CAUSED PINCH VALVE ACTUATOR TO PINCH VALVE VL64 TO MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A 20 ML OF CLEAR FLUID LEAK FROM UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE RUNNING STARTUP. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED. THE OPERATOR 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
    231575 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1