BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2656893 · Received July 16, 2012

    Report

    Report Number
    1061932-2012-02129
    Event Type
    Malfunction
    Date Received
    July 16, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THERE WAS A DILUENT LEAK IN THE RIGHT DILUTER PANEL OF THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER). CUSTOMER INDICATED THAT THE DILUENT ALSO LEAKED ONTO THE COUNTER. CUSTOMER REPORTED THAT THE HMX AUTOLOADER WAS NOT GIVING DIFFERENTIAL RESULTS. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS 10 - 20 CUBIC CENTIMETER. CUSTOMER INDICATED THAT THEY WERE WEARING LAB GOWN, GLOVES AND GLASSES. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE SOURCE OF THE LEAK WAS A CUT TUBING AT PINCH VALVE (PV) 49 AND PV27. PV49 IS THE PATHWAY FOR PRESSURIZED DILUENT USED FOR BACKWASH. PV27 IS THE PATHWAY FOR ERYTHROLYSE (PAK LYSE) FROM THE ERYTHROLYSE PUMPS (PM6, PM7). THE FSE REPLACED THE TUBING GOING THROUGH BOTH PINCH VALVES. THE HMX AUTOLOADER PROVIDED DIFFERENTIAL RESULTS ONCE PV27 WAS REPLACED. SAMPLES WERE RUN AND VERIFIED ON A BACKUP ANALYZER. NO FURTHER LEAKING WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1