BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2119185 · Received June 9, 2011

    Report

    Report Number
    2122870-2011-01697
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT LARGE DIAMETER PERI-PUMP TUBING WAS DISCONNECTED FROM THE INSTRUMENT CAUSING THE LIQUID WASTE LEAK. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE (B)(4) 2011. FSE FOUND A KINK IN THE EXTERNAL WASTE TUBING. KINK WAS REMOVED AND THE LEAK WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A LIQUID WASTE LEAK IN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THERE WAS NO EXPOSURE TO BIO-HAZARDOUS FLUIDS AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1