BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 2970675 · Received February 20, 2013

    Report

    Report Number
    1061932-2013-00226
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PINCH VALVE LV14 CONTROLS THE DRAIN FOR THE WBC BATH WHEN ACTUATED AND THE RED BLOOD CELL (RBC) BATH WHEN IT IS TURNED OFF. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK AT THE WHITE BLOOD CELL (WBC) BATH OF THE COULTER ACT DIFF ANALYZER. THE VOLUME OF THE LEAK WAS NOT SPECIFIED BUT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES 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. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE WBC BATH WAS OVERFLOWING AND NOT DRAINING. THE FSE REPLACED PINCH VALVE (LV14) AND THE LEAK WAS RESOLVED. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74350 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1