BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3191747 · Received June 26, 2013

    Report

    Report Number
    1061932-2013-01287
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE OBSERVED A SMALL LEAK IN THE DIFFERENTIAL LYSE TUBING FROM THE DIFFERENTIAL HEATER TO THE SHEAR VALVE. THE FSE REPLACED THE TUBING RESOLVING THE LEAK. THE FSE ALSO STATED THAT HE FOUND THE DIFFERENTIAL WASTE CHAMBER (VC13) WAS NOT DRAINING DUE TO THE PORT FROM THE 5 PSI TO THE WASTE CHAMBER WAS PLUGGED. SERVICE ACTIVITIES WERE PERFORMED AND WERE VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURE. FAILURE MODE IS RELATED TO A LEAK AT THE DIFFERENTIAL LYSE TUBING. ALSO VC13 WAS NOT DRAINING DUE TO A PLUGGED PORT FROM 5 PSI. 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 DRY FLUID ON THE TRAY UNDER SHEAR VALVE 85/87 OF THE COULTER LH 780 HEMATOLOGY ANALYZER WHILE CLEANING THE INSTRUMENT. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT, PROTECTIVE EYEWEAR, AND GLOVES 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 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290949 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1