BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)

    MDR report key: 3191746 · Received June 26, 2013

    Report

    Report Number
    2050012-2013-00439
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND EXAMINED THE SYSTEM. THE FSE INITIALLY REPLACED THE MC COLLAR WASH, SAMPLE PROBE, T-VALVE, AND SYRINGE; HOWEVER THE LEAKING WAS STILL OBSERVED. THE FSE THEN REPLACED THE MC SOLENOID VACUUM VALVE WHICH RESOLVED THE ISSUE. THE FSE CONFIRMED THAT THE MC SOLENOID VACUUM VALVE WAS THE PRIMARY FAILURE MODE FOR THIS EVENT. ALIGNMENTS WERE ALSO VERIFIED ON THE MC SAMPLE PROBE AND THE FSE VERIFIED SYSTEM PERFORMANCE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A MODULAR CHEMISTRY (MC) SAMPLE PROBE AND COLLAR WASH LEAK IN THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM (FULL SYSTEM). THE CUSTOMER NOTICED FLUID DRIPPING FROM THE MC SAMPLE PROBE AND COLLAR WASH AND FLUID ON THE CAPPED SAMPLE COLLECTION TUBES. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND GOGGLES AT THE TIME OF THE INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED. THE LABORATORY'S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. 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
    290690 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 880I NA

    Patients

    Seq Age Sex Outcome Treatment
    1