BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3241825 · Received July 22, 2013

    Report

    Report Number
    2050012-2013-00510
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED OVERFLOWING OF LIQUID FROM THE CAP PIERCER BLADE WASH. THE FSE OBSERVED DEBRIS AT THE BOTTOM OF THE BLADE WASH WELL AND NOTED THAT THIS OCCLUDED THE VACUUM/FLUID FLOW. THE FSE FLUSHED THE WASTE LINES AND VACUUM LINE FROM THE WASTE VALVE. SERVICE ACTIVITY WAS VERIFIED. THE FAILURE MODE IS AN OBSTRUCTED CAP PIERCER BLADE WASH CHAMBER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL INSTRUMENT CAP PIERCER WAS LEAKING AND LIQUID WAS OBSERVED ON THE TOP OF THE SAMPLE TUBE CAPS. THE CUSTOMER DISABLED THE CAP PIERCER AND CONTINUED TO RUN THE INSTRUMENT WITH THE SAMPLE TUBE CAPS REMOVED. THE ISSUE WAS REFERRED TO A BEC FIELD SERVICE ENGINEER (FSE). THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL / RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340812 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1