BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2991758 · Received March 6, 2013

    Report

    Report Number
    1061932-2013-00298
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM LEAKED BLOOD FROM THE ASPIRATION PROBE AS THE PROBE TRAVELED TO AMTC (AIR MIX TEMPERATURE CHAMBER) TO DELIVER BLOOD AND RETURNED TO THE HOME POSITION. THE LEAK WAS LESS THAN 1ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GOGGLES, GLOVES, AND A LAB COAT AT THE TIME OF THE EVENT. THERE WAS NO INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO ERRONEOUS RESULTS WERE GENERATED. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE VACUUM TUBING AT PV341 WAS WORN AND NOT WORKING PROPERLY. THE FSE REPLACED THE VACUUM TUBING AT PV341 AND RESOLVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94983 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1