BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 3031772 · Received April 2, 2013

    Report

    Report Number
    2050012-2013-00235
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BECKMAN COULTER
    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) OBSERVED BROKEN PIECES OF BLADE UNDER THE SHUTTLE AND ON THE BASE OF THE CAP PIERCER. THE FSE REPLACED THE WICK AND RESOLVED THE ISSUE. THE FSE PRIMED THE BLADE WASH MULTIPLE TIMES AND NO EVIDENCE OF FLUID LEAK WAS OBSERVED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. WICK. (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED APPROXIMATELY A FEW MILLILITERS OF WASH SOLUTION (COMPOSED OF 99% DEIONIZED WATER AND 1% WASH CONCENTRATE) LEAKED ON TOP OF SAMPLE TUBES DURING UNLOADING OF THE SAMPLE RACK FROM THE UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER NOTED THE CAP PIERCER WAS NOT EVACUATING THE BLADE WASH, CAUSING IT TO DRIP ON THE SAMPLE TUBES AND RACK. THE CUSTOMER ALSO NOTED TUBE VENTING ERROR OCCURRED DURING SAMPLE ANALYSIS. THE CUSTOMER STATED NO ERRONEOUS RESULTS WERE GENERATED, AND THERE WAS NO PATIENT IMPACT. THE OPERATOR WAS WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE LABORATORY HAS AN EXPOSURE CONTROL PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134344 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1