BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2908963 · Received January 10, 2013

    Report

    Report Number
    1061932-2013-00035
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE FOUND A FLUIDIC LEAK IN THE DILUTER, VC26 NOT DRAINING. THE FSE ALSO FOUND A LEAK IN THE SHEATH RESTRICTOR TUBING AT THE VL46B. THE FSE REPLACED THE TUBING AND CLEANED UP FLUID IN THE DILUTER. THE FSE ALSO FLUSHED VENT PATHWAY TO VC26. THE FSE ALSO FOUND VC26 PORT FROM VL53D PLUGGED SO NO PRESSURE WAS APPLIED TO THE DRAIN. THE FSE REMOVED THE PLUG FROM PORT AND FLUSHED PORT THAT FIXED THE LEAK. LEAK WAS RESOLVED. FAILURE MODE: VC26 PORT FROM VL53D PLUGGED. PER LABELING, 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THERE WAS A LEAK OF CLEAR FLUID DRIPPING FROM UNDER THE COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF FLUID WAS 30 MLS. THE CUSTOMER WAS WEARING PROPER PROTECTIVE EQUIPMENT (PPE), INCLUDING A LAB COAT AND GLOVES DURING THIS EVENT. THERE WAS NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13449 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1