BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM CONTINU-FLOSOLUTION SET

    MDR report key: 1760264 · Received July 16, 2010

    Report

    Report Number
    6000001-2010-01734
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) THAT THE UPPER Y-SITE OF THE CLEARLINK CONTINU-FLO SOLUTION SET IS LOOSE CAUSING A SEPARATION. A DIFFERENT CLEARLINK CONTINU-FLO SOLUTION SET IS BEING CONNECTED TO THE Y-SITE. THE SEPARATION OCCURRED DURING PATIENT USE WITH AN UNKNOWN SOLUTION THAT LEAKED. THERE WAS NO PATIENT INJURY DUE TO THE CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM CONTINU-FLOSOLUTION SET STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - CLEVELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1