BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3083598 · Received April 29, 2013

    Report

    Report Number
    1061932-2013-00664
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT AND FOUND LOOSE SAMPLE LINE AT BOTTOM OF FLOWCELL. THE FSE REPLACED THE ORIGINAL SAMPLE LINE WITH NEW SAMPLE LINE AND VERIFIED NORMAL OPERATION. 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. FAILURE MODE WAS THE LOOSE SAMPLE LINE AT BOTTOM OF FLOWCELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER A CLEAR FLUID LEAK AT THE MIXING CHAMBERS ON THE UNICEL DXH 800 COULTER INSTRUMENT. THE LEAK WAS NOTICED AFTER DOING THE DAILY CHECK COMING OUT OF SHUTDOWN. THE CUSTOMER COULD NOT LOCATE THE EXACT SOURCE OF THE LEAK. THE LEAK VOLUME WAS <20 ML, AND IT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEETS (MSDS) ARE ONSITE AND DID NOT NEED TO BE REVIEWED. THERE IS A RISK MANAGEMENT EXPOSURE CONTROL PLAN IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTION EQUIPMENT (PPE), CONSISTING OF GLOVES, GOGGLES AND A LABORATORY COAT. THERE WAS NO BIOHAZARD EXPOSURE TO ANYONE, AND NO CONTACT TO OPEN OR BROKEN SKIN OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. THERE WERE NO PATIENT RESULTS AFFECTED. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185245 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1