BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2884157 · Received December 21, 2012

    Report

    Report Number
    2050012-2012-01956
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE WASH STATION WAS NOT DRAINING AND REPLACED THE PUMP ASSEMBLY TO RESOLVE THE ISSUE. SERVICE ACTIVITY WAS VERIFIED PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. RESULTS: ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CLOSED TUBE ALIQUOTTER (CTA) ACTIVE WASH STATION AND PIERCER LUBRICATING STATIONS OVERFLOWED INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND CLEANED UP THE FLUID SPILL. THE CUSTOMER PERFORMED SYSTEM TROUBLESHOOTING AND NO ISSUES WERE NOTED. PATIENT RESULTS WERE NOT GENERATED; THERE WAS NO PATIENT IMPACT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSTRUMENT UNTIL SERVICE IS COMPLETE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1