BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3223208 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01453
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT TUBING #207 FROM THE BLOOD SAMPLING VALVE (BSV) TO THE WHITE BLOOD CELL (WBC) BATH HAD POPPED OFF AND DILUENT HAD SPRAYED INTO THE SHEAR VALVES AND THE ELECTRICAL CONNECTORS OF THE DIFFERENTIAL / RETIC HEATERS. THE FSE CLEANED THE AREAS OF ALL THE FLUID AND DRIED ALL ELECTRICAL CONNECTORS. THE FSE ALSO REATTACHED THE TUBING WHICH FIXED THE LEAK, LOW VACUUM DRIFT ERRORS AND WBC VOTE OUT. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A BLOODY LEAK ON THE COULTER LH 780 HEMATOLOGY ANALYZER AFTER CHANGING DILUENT AND RUNNING A BACKGROUND. THE VOLUME OF LEAK WAS 2-3 MLS AND WAS NOT CONTAINED WITHIN THE UNIT. THE CUSTOMER ALSO INDICATED THAT THE INSTRUMENT WAS GENERATING "LOW VACUUM DRIFT" AND WHITE BLOOD CELL (WBC) VOTE OUT ERRORS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES, AND A FACE SHIELD AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324417 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1