BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3171770 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01109
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED THE UNIT WAS EXPERIENCING A BATH OVERFLOW. THE FSE FOUND THE WASTE PUMP AND VACUUM PUMP WAS NOT WORKING. THE WASTE PUMP DRAINS THE WHITE BLOOD CELL (WBC) BATH, THE RED BLOOD CELL (RBC) BATH, AND THE VACUUM CHAMBER (VC1). THE FSE REPLACED THE WASTE PUMP, TUBING, AND THE VACUUM PUMP. THE FSE ALSO CHECKED ALL PINCH VALVES FOR PROPER OPERATION, AND NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. THE CAUSE OF THE LEAK WAS ATTRIBUTED TO A FAULTY WASTE PUMP AND VACUUM PUMP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE COULTER AC *T DIFF 2 ANALYZER WAS LEAKING. THE VOLUME OF THE LEAK WAS APPROXIMATELY 10 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273929 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1