BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2180155 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-00954
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER, INC. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT A LEAK WAS OBSERVED IN THE BOTTOM TRAY UNDER THE SECONDARY PROBE OF THEIR COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS DISCOVERED WHEN THE CUSTOMER WAS PERFORMING ROUTINE CLEANING AND MAINTENANCE ON THE ANALYZER. NO PATIENT SAMPLES WERE BEING ANALYZED AT THE TIME OF THE EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE - LAB COAT, GLOVES) AT THE TIME OF THE EVENT. THERE WAS NO INJURY OR EXPOSURE TO THE OPERATOR. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE CUSTOMER CLEANED THE LEAK AND THEN EXECUTED A STARTUP OF THE ANALYZER. THE CUSTOMER OBSERVED THAT FLUID WAS BUILDING UP IN THE BOTTOM TRAY UNDER THE SECONDARY PROBE AGAIN. THE CUSTOMER REQUESTED SERVICE TO REPAIR THE ANALYZER. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. THE CUSTOMER DID NOT REVIEW THE MATERIAL SAFETY DATA SHEET (MSDS); HOWEVER, IT IS READILY AVAILABLE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(6) 2011. THE FSE REPLACED THE SECONDARY PROBE. THE ROOT CAUSE OF THIS EVENT WAS ATTRIBUTED TO A LEAK OF THE SECONDARY PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1