BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 2889740 · Received December 28, 2012

    Report

    Report Number
    1061932-2012-02933
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING VIA THE TELEPHONE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-ERRONEOUS HEMOGLOBIN AND HEMATOCRIT RESULTS DID NOT CORRELATE AND APPROXIMATELY TEN (10) MILLILITERS OF CLEAR FLUID LEAKED FROM THE RED BLOOD CELL (RBC) BATH INVOLVING THE COULTER ACT DIFF 12 ANALYZER. THE CUSTOMER DETERMINED THE RBC BATH WAS NOT DRAINING AND OVERFLOWING. THE CUSTOMER WAS ADVISED TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING AND HAD ON GLOVES. THE CUSTOMER WAS ADVISED TO MANUALLY DRAIN THE RBC BATH USING DRAIN FUNCTION M12-DRN; APPROXIMATELY FOUR ATTEMPTS WERE MADE TO COMPLETELY DRAIN THE BATH. THE CUSTOMER INSTRUCTED THE CUSTOMER TO RINSE THE RBC BATH WITH HOUSEHOLD BLEACH AND DRAIN THE BATH UTILIZING DRAIN FUNCTION M12-DRN; THE BLEACH COMPLETELY DRAINED ON THE THIRD DRAIN. THE CUSTOMER WAS ADVISED TO REPEAT THE PROCESS AND NOTED THE BLEACH DRAINED ON THE FIRST DRAIN AND VERIFIED THE RBC BATH WAS DRAINING PROPERLY. THE CUSTOMER PERFORMED SYSTEM STARTUP, AND ALL PARAMETERS PASSED. THE CUSTOMER REANALYZED THE ORIGINAL PATIENT SAMPLE AND NOTED HEMOGLOBIN AND HEMATOCRIT VALUES CORRELATED. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE ISSUE WAS RESOLVED, AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER HAS A RISK MANAGEMENT PLAN AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 12¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1