BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3336846 · Received September 9, 2013

    Report

    Report Number
    1061932-2013-01940
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    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 INDICATED THAT THE ASPIRATION TUBING HAD POPPED OFF OF THE PORT ON THE BLOOD SAMPLING VALVE (BSV) DUE TO POSSIBLY BEING TANGLED WITH THE SAMPLE ASPIRATION MODULE (SAM). THE FSE REPLACED THE TUBING AND CLEANED THE BSV. THE FSE VERIFIED INSTRUMENT OPERATION. FAILURE MODE IS RELATED TO DISCONNECTED ASPIRATION TUBING AT THE BSV. 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. BEC IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THERE WAS A FLUID LEAK OF APPROXIMATELY 1 ML COMING FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED ASPIRATION ERRORS PRIOR TO THE DISCOVERY OF THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND FACE PROTECTION AT THE TIME OF OCCURRENCE. IT IS UNKNOWN IF 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. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450341 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1