BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 8/10 ANALYZER

    MDR report key: 2981693 · Received February 27, 2013

    Report

    Report Number
    1061932-2013-00238
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND NOTED THAT THE WBC BATH WAS OVERFLOWING. FSE FOUND THAT THE TUBING THROUGH PINCH VALVE LV14 WAS CLOGGED. PINCH VALVE LV14 CONTROLS THE DRAIN FOR THE RBC AND WBC BATHS. FSE FLUSHED THE TUBING THROUGH LV14 AND THE LEAK WAS RESOLVED. FSE ALSO REPLACED THE DILUENT FILTERS AS PREVENTIVE MAINTENANCE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER HAD REPLACED THE DILUENT AND THE INSTRUMENT WAS NO LONGER GIVING 'DILUENT LOW' MESSAGES WHEN THE FSE NOTICED THE LEAK. THE 'DILUENT LOW' MESSAGES WERE NOT RELATED TO THE LEAK. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE TUBING THROUGH LV14 BEING CLOGGED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK AT THE BATHS OF A COULTER ACT 8/10 ANALYZER. THE INSTRUMENT WAS BEING PRIMED AND WAS GIVING "DILUENT LOW" MESSAGES WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS 10 ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A GOWN AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84217 COULTER® ACT 8/10 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT 8/10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1