BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2895369 · Received January 3, 2013

    Report

    Report Number
    1061932-2012-02910
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THE NEEDLE BELLOWS OF THE COULTER LH 780 HEMATOLOGY ANALYZER WAS NOT DRAINING. CUSTOMER REPORTED THAT THERE WAS A SMALL AMOUNT OF FLUID AROUND THE BELLOWS AND NEEDLE AREA. CUSTOMER REPORTED THE FLUID APPEARED TO BE THE BACKWASH FLUID FROM THE NEEDLE BELLOWS. CUSTOMER REPORTED APPROXIMATELY 3 ML OF THE FLUID SPILLED AROUND THE NEEDLE DRIP TRAY. CUSTOMER INDICATED THAT THERE WAS SOME MOISTURE ON THE CAPS ON THE TUBES. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE NEEDLE BELLOWS OVERFLOWED ON THE INSTRUMENT. THE FSE DETERMINED THE LEAK WAS FROM THE BELLOWS WASTE LINE WHICH HAD A CLOT OBSTRUCTING THE DRAIN LINE AND WAS NOT DRAINING PROPERLY. THE FSE ALSO FOUND VALVE 57A (VL57A) ACTUATOR WHICH DRAINS THE NEEDLE AND PROBE WASTE WITH VACUUM WAS NOT WORKING. THE FSE REPLACED THE BELLOWS WASTE LINE TO RESOLVE THE LEAK AND REPLACED THE VL57A ACTUATOR TO RESOLVE THE ACTUATOR NOT WORKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3381 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1