BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 2242638 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05057
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, FIELD SERVICE ENGINEER (FSE) FOUND THAT SYRINGE WAS GETTING MOVE ERRORS ON R- SYRINGE PUMP. THE FSE REPLACED THE LEFT SYRINGE PUMP 3-WAY VALVE. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A FLUID LEAK ON UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THAT UCTA (UNICEL CLOSED TUBE ALIQUOTTER) RIGHT SAMPLE SYRINGE PLUNGER OVERLOADED AND THE SYRINGE HAD BEEN LEAKING. NO ERRONEOUS RESULT WAS GENERATED. THE CUSTOMER WAS WEARING LAB COAT AT THE TIME OF THE EVENT. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1