BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3951347 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01694
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 OBSERVED THE TUBING FROM THE BACKWASH MANIFOLD (MF4) BECAME DISCONNECTED FROM THE CHECK VALVE. THE FSE REATTACHED THE TUBING, INSTALLED A NEW CHECK VALVE AND THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS. THE INSTRUMENT CONTINUED TO GIVE ASPIRATION ERRORS DUE TO THE LEAK HAD DAMAGED THE SOLENOIDS (9, 24, 37 AND 64). THE FSE REPLACED THE SOLENOIDS AND THE INSTRUMENT PERFORMED WITHOUT ANY 'ASPIRATION' ERRORS. THE FSE ALSO OBSERVED THE WBC APERTURES WERE CONTAMINATED WITH PROTEIN BUILD UP CAUSING THE INSTRUMENT TO GENERATE A WHITE BLOOD CELL (WBC) VOTE OUTS. THE FSE CLEANED THE APERTURES TO RESOLVE THE WBC VOTE OUTS. THE FSE ALSO REPLACED MANIFOLD (MF13) AND THE TUBING AT THE WBC BATH AS PREVENTIVE MAINTENANCE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 15 MLS OF DILUENT LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. 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
    428429 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1