BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3071931 · Received April 22, 2013

    Report

    Report Number
    1061932-2013-00628
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 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

    REVIEW OF THE ANALYZER'S RECORDS, SHOWS THE DXH800 GENERATED ERROR MESSAGES AT THE TIME OF THIS EVENT. THE FSE CLEANED THE DISTRIBUTION VALVE (DV) AND REPLACED THE TUBING ON BOTTOM OF THE FLOW CELL TO RESOLVE THE LEAK. THE FSE CYCLED THE DV WITH NO ERRORS. THE FSE VERIFIED LATRON, AND RAN QUALITY CONTROL (QC); ALL RESULTS WERE WITHIN RANGE. THE FSE INDICATED THAT ALL DAILY CHECKS PASSED. FAILURE MODE WAS DISCONNECTED TUBING FROM BOTTOM OF THE FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED TO BECKMAN COULTER THAT THE DISTRIBUTION VALVE (DV) ON THE UNICEL DXH 800 COULTER INSTRUMENT WAS NOT HOMING AND THE LATRON CONTROL WAS VOTING OUT AND HEARD A GRINDING SOUND INSIDE THE ANALYZER. WHILE TROUBLESHOOTING THE DV CYCLE ISSUES ON THE CUSTOMER'S DXH 800 INSTRUMENT, THE FIELD SERVICE ENGINEER (FSE) FOUND TUBING THAT HAD POPPED OFF THE BOTTOM PORT OF THE FLOW CELL AND AT LEAST 200 CC OF DILUENT, LIKELY CONTAMINATED WITH BLOOD AND CONTROL MATERIAL, LEAKED FROM THE INSTRUMENT INTO THE PULL OUT WORK SHELF OF THE ANALYZER'S FLOOR STAND. THE LEAK WAS CONTAINED WITHIN THE FLOOR STAND AND THE CUSTOMER WAS UNAWARE OF THE SPILL. THE LEAK WAS NOT RELATED TO THE DV ISSUE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172319 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1