BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AL HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2180209 · Received July 27, 2011

    Report

    Report Number
    1061932-2011-00960
    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
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REVIEWED THE MATERIAL SAFETY DATA SHEET (MSDS). THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. 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 HIGH PITCHED SOUND AND NO WBC (WHITE BLOOD CELL) RESULTS FOR THEIR COULTER HMX AL HEMATOLOGY ANALYZER WITH AUTOLOADER. THERE WERE NO ERRONEOUS RESULTS GENERATED NOR WERE RESULTS REPORTED OUT OF THE LABORATORY AT THE TIME OF THE EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE CUSTOMER DISCONTINUED USE OF THE ANALYZER AND REQUESTED SERVICE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE DISCOVERED CUT TUBING AT VL66 AND VL14. A SMALL VOLUME OF ISOTON AND CLENZ SOLUTIONS HAD SPILLED ONTO THE BACK WALL OF THE CBC MODULE BEHIND THE ISOLATOR CHAMBER AND HEMOGLOBIN SOCKET. NO BLOOD WAS OBSERVED. PERSONAL PROTECTIVE EQUIPMENT (PPE - LAB COAT, GLOVES, GLASSES WITH SHIELD PROTECTOR) WAS WORN WHILE CLEANING THE ISOTON AND CLENZ SOLUTIONS WITH GAUZE AND 10% BLEACH IN DISTILLED WATER. THE FSE REPLACED THE CUT TUBING. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. ALL RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THERE WAS NO INJURY OR EXPOSURE TO THE CUSTOMER. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1