BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2579410 · Received May 18, 2012

    Report

    Report Number
    2050012-2012-01103
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    April 20, 2012
    Report Date
    April 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE DAY OF THE EVENT, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE THE EVENT. THE FSE FOUND A CLOT OCCLUDING THE MODULAR CHEMISTRY SAMPLE VALVE. THE FSE REMOVED THE OCCLUSION, WHICH RESOLVED THE ISSUE. SERVICE ACTIVITY PERFORMED IS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE ROOT CAUSE OF THE EVENT WAS THE OBSTRUCTION OF THE MODULAR CHEMISTRY SAMPLE VALVE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE MODULAR CHEMISTRY SAMPLE PROBE ON THE UNICEL DXC800P SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER ALSO REPORTED VACUUM WAS NOT OPERATIONAL. THE CUSTOMER STATED THE FLUID IS COMING OUT OF THE COLLAR WASH AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER CLEANED THE LEAK WITH A GAUZE. THE CUSTOMER DID NOT REPORT COLLAR WASH OBSTRUCTION THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, EYE PROTECTION, AND GLOVES. THE CUSTOMER DID NOT COME IN CONTACT WITH THE FLUID AND DID NOT SEEK MEDICAL ATTENTION. NO EXPOSURE (SPRAYED OR SPLASHED) TO MUCOUS MEMBRANES OR OPEN WOUNDS WERE REPORTED. NO DEATH, INJURY OR CHANGES TO PATIENT TREATMENT OR RESULTS ARE ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT REVIEW THE MSDS; HOWEVER, THE FACILITY DOES HAVE EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1