BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2110829 · Received June 1, 2011

    Report

    Report Number
    2050012-2011-01960
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011, FOUND EXCESSIVE DRIED UP BUILD AND REMOVED CANISTER, CLEANED THOROUGHLY, REPLACED O-RING AND SECURED FITTINGS. FSE REINSTALLED CANISTER AND PRIMED SEVERAL TIMES WITHOUT NOTICEABLE LEAKING. ON (B)(4) 2011, FSE RETURNED AND INSPECTED WASH CONCENTRATE RESERVOIR CANISTER FOR LEAKS, NO LEAKING WAS OBSERVED AFTER CLEANING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WAS LEAKING FROM THE WASH CONCENTRATE RESERVOIR CANISTER. NO INJURY WAS REPORTED.

    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