BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3981947 · Received August 5, 2014

    Report

    Report Number
    1061932-2014-01813
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE DETERMINED THE LIQUID FOUND WAS DUE TO A SPILL FROM THE SECONDARY PROBE WASH; THE AREA WAS CLEANED AND THERE WERE NO FURTHER LEAKS. TO ADDRESS THE DIFFERENTIAL SAMPLE PRESSURE ERRORS, THE FSE REPLACED RED TUBING TO THE TOP OF DIFFERENTIAL MIX CHAMBER AND DIFFERENTIAL SAMPLE PRESSURE REGULATOR. ALIGNMENT WAS PERFORMED. THE CUSTOMER LATER REPORTED INTERMITTENT DIFFERENTIAL SAMPLE PRESSURE ERRORS AGAIN. THE FSE RETURNED AND REPLACED ACTUATORS ON VL89, 41, 45, 51, AND 54 AS WELL AS THE PERFORMANCE VERIFICATION TEST PRINTED CIRCUIT BOARD. THERE WERE NO FURTHER REPORTS OF ERRORS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SMALL POOL OF LIQUID WHILE TROUBLESHOOTING A COULTER LH 780 HEMATOLOGY ANALYZER FOR INTERMITTENT DIFFERENTIAL SAMPLE PRESSURE ERRORS. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES, GOGGLES, AND A LAB COAT WHEN THE LEAK WAS FOUND. THERE WERE NO REPORTS OF BIOHAZARD EXPOSURE TO THE LEAK. PATIENT RESULTS WERE NOT AFFECTED AND THERE WAS NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457577 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1