BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3982396 · Received August 6, 2014

    Report

    Report Number
    1061932-2014-01827
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    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

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE CONFIRMED FLUID LEAK UNDERNEATH THE BLOOD SAMPLING VALVE (BSV). THE FSE OBSERVED A BENT NEEDLE CARTRIDGE AND SOLENOID (VL62) WAS NOT ACTIVATING. THE NEEDLE CARTRIDGE WAS REPLACED, RESOLVING THE LEAK. THE FSE ALSO OBSERVED THE DILUTER 3 CARD HAD FAILED, CAUSING THE SOLENOID (VL62) TO NOT ACTIVATE. THE FSE PERFORMED STARTUP AND REPRODUCIBILITY TO VERIFY NORMAL ASPIRATION AND DRAINAGE CIRCUIT. THE INSTRUMENT PASSED LATRON AND ALL LEVELS OF CONTROLS. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BLOODY FLUID LEAKED UNDERNEATH THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 780 HEMATOLOGY ANALYZER ONTO THE COUNTER. THE VOLUME OF THE LEAK IS UNKNOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, EYE GLASSES AND A LAB COAT AT THE TIME OF THE INCIDENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461469 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1