BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC.T DIFF ANALYZER

    MDR report key: 4163525 · Received October 10, 2014

    Report

    Report Number
    1061932-2014-02499
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE DISCOVERED OVERFILLING WHITE BLOOD CELL (WBC) BATH AND RED BLOOD CELL (RBC) BATH THAT WAS NOT FILLING. THE FSE REPLACED FAILING SOLENOID VALVES (LV14 AND LV15) TO RESOLVE THE ISSUE. THE FSE THEN PERFORMED VERIFICATION OF INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED BLOODY FLUID LEAK OF APPROXIMATELY THIRTY (30) ML FROM THE BOTTOM OF THE COULTER AC.T DIFF ANALYZER. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING GLOVES AND LABORATORY COAT WHEN THE LEAK OCCURRED. 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
    639321 COULTER AC.T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1