BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 3123074 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00855
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND CONFIRMED THE LEAK. THE FSE NOTICED THAT BATHS WERE OVERFLOWING AND THE VIC (VACUUM ISOLATION CHAMBER) WAS NOT DRAINING DUE TO A CLOG IN THE LINE LEADING TO THE WASTE CONTAINER. THE FSE REPLACED THE TUBING FROM THE WASTE PUMP TO THE WASTE CONTAINER AND EMPTIED THE VACUUM OVERFLOW CHAMBER TO RESOLVE THE LEAK. FAILURE MODE IS ATTRIBUTED TO A CLOG IN THE LINE LEADING TO THE WASTE CONTAINER WHICH CAUSED THE VACUUM TO BE BACKED UP WITH FLUID AND THE BATHS TO OVERFLOW. RESULTS: CLOG IN THE TUBING LEADING TO THE WASTE CONTAINER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAK OF APPROXIMATELY 10-20 ML FROM THE BATHS OF THE COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED. THE CUSTOMER 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
    224853 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1