BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF 2 ANALYZER

    MDR report key: 4201280 · Received October 27, 2014

    Report

    Report Number
    1061932-2014-02666
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND THE LEAK WAS DUE TO CLOGGED RED BLOOD CELL (RBC) AND WHITE BLOOD CELL (WBC) BATHS. THE FSE CLEANED THE BATHS AND THE INSTRUMENT RAN WITHOUT LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED CLENZ FLUID LEAK OF APPROXIMATELY FIVE (5) ML FROM AN UNKNOWN SOURCE INSIDE THE COULTER AC.T DIFF 2 ANALYZER DURING STARTUP. THE INSTRUMENT DID NOT GENERATE ANY ALARMS OR ERRORS WHEN THE LEAK OCCURRED. THE CUSTOMER STATED THE INSTRUMENT WAS A BACKUP INSTRUMENT AND THAT THE STARTUP FAILED PLATELET (PLT) AND HEMOGLOBIN (HGB). THERE WAS NO REPORT OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE FLUID, OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE PROTECTION, AND LABORATORY COAT WHEN THE LEAK WAS DISCOVERED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682837 COULTER AC.T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1