BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3223122 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01442
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A BROWN LIQUID IN THE DRIP TRAY OF THE PROBE WIPE AND DRIED BLOOD UNDER THE NEEDLE ASSEMBLY. THE FSE REMOVED THE NEEDLE ASSEMBLY AND ROCKER BED AND CLEANED BOTH AND REINSTALLED. THE FSE ALSO FOUND THAT THE PATHWAY FOR THE WASTE/DRAIN OF THE NEEDLE WAS SLOW AND CAUSING LIQUID TO BE PUSHED OUT OF THE BELLOWS WHEN THE BELLOWS COLLAPSED. THE FSE FLUSHED THE PATHWAY WITH BLEACH AND FOUND THAT THE CONTROL VALVE (CV) 40B WAS BLOCKED WITH A CLOT. THE FSE REPLACED THE CV40B WHICH RESOLVED THE LEAK. 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) STATING THAT LIQUID LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE VOLUME OF LEAK WAS ABOUT 200 MLS AND WAS NOT CONTAINED WITHIN THE UNIT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND PROTECTIVE EYEWEAR AT THE TIME OF THE EVENT. 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 IN CONNECTION TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323917 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1