BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3903593 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01533
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE FAULTY SWEEP FLOW CHECK VALVE, CV150. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VOLUME OF THE RED BLOOD CELL (RBC) BATH DECREASED WITH THE INSTRUMENT AT IDLE AND RBC APERTURE VOTE-OUTS WERE OBTAINED INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER INDICATED NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY AND OBSERVED A FAULTY SWEEP FLOW CHECK VALVE, WHICH CAUSED A BACKFLOW IN THE SWEEP FLOW SUPPLY LINE DURING SYSTEM IDLE. THE FSE REPLACED CHECK VALVE CV150 AND RESOLVED THE REPORTED ISSUE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379119 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1