BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2575545 · Received May 16, 2012

    Report

    Report Number
    2050012-2012-01100
    Event Type
    Malfunction
    Date Received
    May 16, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE LEAKING, PER THE FSE, WAS EITHER PINCHED UCTA DRAIN TUBING AND/OR AN OCCLUSION IN THE ACTIVE WASH STATION DRAIN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) A LEAK ON THE BOTTOM OF THE CLOSE TUBE ACCESSION (CTA) ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT THE LEAKING FLUID WAS WASH BUFFER II AND BIOLOGICAL FLUIDS/WASTE FROM THE DRAIN LINES. 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. CTS GENERATED SERVICE REQUEST TO INVESTIGATE THE EVENT. ON (B)(6) 2012 A FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING SERVICES ON THE INSTRUMENT: THE FSE FOUND LEAKING FROM THE OVERFLOW BOTTLE AND THE ACTIVE WASH STATION; THE BOTTLE WAS REMOVED AND CLEANED. DRAIN PUMP TUBING WAS REPLACED. ACTIVE WASH STATION WAS REMOVED AND REPLACED. A CARRYOVER TEST WAS PERFORMED AND PER FSE WAS "OK." DRAIN LINE WAS CHECKED FOR KINKS AND OCCLUSION NONE FOUND. SERVICE ACTIVITY WAS VERIFIED AND MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1