BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3160764 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01154
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2013 TO EVALUATE THE INSTRUMENT. THE FSE FOUND THAT THE LEAK WAS CLENZ AND DILUENT ONLY. THE FSE DISCOVERED THAT THE LEAK WAS COMING FROM A DISCONNECTED TUBING AT THE TOP PORT OF THE UPPER SHEATH RESTRICTOR. THE FSE REPLACED THE TUBING AND CLEANED UP THE LIQUID SPILL. FAILURE MODE OF THE LEAK IS RELATED TO DISCONNECTED TUBING AT THE TOP PORT OF THE UPPER SHEATH RESTRICTOR. THE INSTRUMENT GENERATED SHEATH TANK AND LOW VACUUM ERRORS ALERTING THE CUSTOMER TO AN INSTRUMENT PROBLEM. 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

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT APPROXIMATELY 20 MLS OF BLUE FLUID LEAKED ON THE LOADING BAY SIDE OF THE ROCKER BED IN THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT GENERATED SHEATH TANK AND LOW VACUUM ERRORS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES 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 FOR THIS EVENT. NO SAMPLES WERE ABLE TO BE RUN DUE TO SHEATH TANK AND LOW VACUUM ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260437 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1