BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3233220 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01513
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE HAD OBSERVED THAT THE SOURCE OF THE LEAK WAS FOUND TO BE THE COMPLETE BLOOD COUNT (CBC) LYSE RESTRICTOR TUBING WAS CUT AT THE FITTING. THE FSE REPLACED THE TUBING. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. FAILURE MODE: THE CAUSE OF THE LEAK WAS A CUT TUBING AT THE CBC LYSE RESTRICTOR. 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

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK UNDER THE BATHS OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS APPROXIMATELY 2 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. IT COULD NOT BE CONFIRMED IT THE INSTRUMENT GENERATED ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, GLOVES, AND PROTECTIVE EYEWEAR AT THE TIME OF OCCURRENCE. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT 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 IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333865 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1