BEUDAMED
    FDA Adverse Event Summary report: N

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

    MDR report key: 2080857 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01420
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT BEFORE TROUBLESHOOTING AND INSTRUCTED THE CUSTOMER TO REMOVE THE CAP PIERCER COVER AND CHECK THE WASTE AND WASH TUBING. THE CUSTOMER DID NOT NOTE ANY ISSUES. CTS INFORMED THE CUSTOMER THAT THE PIERCER LEAK WHEN THE BLADE IS WASHED AND ADVISED THE CUSTOMER TO DISABLE THE PIERCER AND POP THE CAPS ON SAMPLES. ON (B)(4) 2011, A BCI FIELD SERVICE ENGINEER (FSE) FOUND WASH SOLUTION COMING OUT CAP PIERCER BLOCK AND V3 IS NOT OPERATING PROPERLY. NO BLOCKAGE IN TUBING WAS NOTED. ON (B)(4)-2011, FSE REPLACED DEFECTIVE VALVE AND THAT RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE PRESENCE OF EXCESS LIQUID ON TOP OF SOME CAPPED SAMPLES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM) DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC 880I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1