BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3022287 · Received March 27, 2013

    Report

    Report Number
    1061932-2013-00438
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE DISCOVERED THAT THE SOURCE OF THE LEAK WAS A DISCONNECTED TUBING AT THE BLOOD SAMPLING VALVE (BSV). THE FSE REPLACED THE AFFECTED TUBING. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED, INSTRUMENT OPERATED WITHOUT ISSUE. THE CAUSE OF THE LEAK WAS THE DISCONNECTED TUBING AT THE BSV. THE INSTRUMENT OPERATED AS INTENDED BY GENERATING ASPIRATION ERRORS ALERTING THE OPERATOR OF THE INSTRUMENT PROBLEM. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, (BEC), THAT THEY OBSERVED THAT BLOOD SAMPLING VALVE (BSV) ON THE UNICEL DXH 800 COULTER INSTRUMENT WAS LEAKING AND GENERATING ASPIRATION ERRORS. THE VOLUME OF THE LEAK WAS APPROXIMATELY 2CC AND WAS CONTAINED WITHIN THE INSTRUMENT. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126810 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1