BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2194271 · Received August 7, 2011

    Report

    Report Number
    1061932-2011-01089
    Event Type
    Malfunction
    Date Received
    August 7, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 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 AN ASPIRATION C ERROR ON THEIR COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER REPORTED THAT THE ASPIRATION C ERROR WAS OCCURRING BEFORE A SAMPLE WAS ASPIRATED. THERE WAS NO IMPACT TO PATIENT RESULTS. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED A BURNED SPOT ON A DRIED PAPER TOWEL THAT HAD BEEN LEFT INSIDE OF THE ANALYZER WHICH BURNED THE DILUTER 2 CARD. THERE WAS NO OTHER EVIDENCE OF FIRE IN THE ANALYZER. THERE WAS NO REPORT OF SMOKE OR FLAMES FROM THE ANALYZER. THE FIRE DEPARTMENT WAS NOT NOTIFIED AND THE USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY INJURIES. THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE FSE REPLACED THE DILUTER 2 CARD AND VERIFIED ANALYZER PERFORMANCE PER ESTABLISHED PROCEDURES. THE DILUTER 2 CARD CONTROLS BLOOD DETECTORS, REAGENT HEATERS, PROBE-WIPE MOTOR, AND REAGENT RESERVOIRS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1