BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AL HEMATOLOGY ANALYZER

    MDR report key: 2180156 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-00959
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 A BLOOD LEAK AT THE SECONDARY PROBE OF THE HMX CAP PIERCE MODULE OF THEIR COULTER HMX AL HEMATOLOGY ANALYZER. NO PATIENT SAMPLES WERE BEING ANALYZED AT THE TIME OF THE EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE BLOOD LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE - LAB COAT, GLOVES, EYE PROTECTION) AT THE TIME OF THE EVENT. THERE WAS NO INJURY OR EXPOSURE TO THE CUSTOMER. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. 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)(4) 2011. THE FSE WAS UNABLE TO REPRODUCE THE PROBLEM. THE FSE OBSERVED THAT THE RINSE BLOCK WAS POSITIONED TOO HIGH ON THE PROBE. THE FSE ADJUSTED THE RINSE BLOCK DOWN TO ITS PROPER POSITION. THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1