BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2823440 · Received November 8, 2012

    Report

    Report Number
    2050012-2012-01826
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REBUILT THE CAP PIERCER WASH ASSEMBLY BY REPLACING THE SHUTTLE, THE QUAD RING, AND THE SHUTTLE CAM FOLLOWER. THE INSTRUMENT PERFORMED WITHIN THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. SHUTTLE, CAM FOLLOWER. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED THE CAP PIERCER BLADE WASH STATION LEAKED DILUTE WASH SOLUTION INSIDE THE INSTRUMENT INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER CLEANED THE DRAIN ELBOW UNDER THE STATION BUT DID NOT RESOLVE THE LEAK ISSUE. THE CUSTOMER STATED NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY. 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 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1