BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3840019 · Received May 30, 2014

    Report

    Report Number
    1061932-2014-01132
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND A QUICK DISCONNECT 8 ON THE FLOW CELL HARNESS UNDER THE SHEATH TANK WAS NOT TIGHT AND WAS LEAKING SLIGHTLY (LINE PROVIDES DILUENT FOR SAMPLE LINE CLEANING AND INTERCONNECTS TO THE SAMPLE LINE) ONTO THE PNEUMATIC SERVICES, TEMP CONTROL CARD AND SHORTED SOLENOIDS. THE FSE TIGHTENED THE QUICK DISCONNECT AND ALSO REPLACED PNEUMATIC MODULE RESOURCE CARD (MRC), PNEUMATIC SENSOR CARD, VOLUME CONDUCTIVITY SCATTER (VCSN) TEMPERATURE CONTROLLER CARD, MODULE ID BOARD AND ASSOCIATED CABLES TO RESOLVE THE ISSUE WITH THE SOLENOIDS DAMAGED BY THE LEAK. THE FSE VERIFIED THE INSTRUMENT WITH NO FURTHER ISSUES. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THE BACK OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WHILE RUNNING LATRON QUALITY CONTROL (QC). THE CUSTOMER STATED A "PNEUMATIC SUPPLY MODULE EXCEEDED THE OPERATING LIMITS" SYSTEM ERROR WAS ALSO OBTAINED. THE CUSTOMER POWERED OFF THE INSTRUMENT. THERE WERE NO SPARKS, ARCS OR FLAMES. THE LAB WAS NOT EVACUATED AND THE FIRE DEPARTMENT WAS NOT CALLED. NO ERRONEOUS RESULTS WERE GENERATED IN ASSOCIATION WITH THE EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318888 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1