BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC

    MDR report key: 3893440 · Received June 3, 2014

    Report

    Report Number
    3893440
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IV PUMP ALARMED DOWNSTREAM OCCLUSION DURING TPN ADMINISTRATION. UNABLE TO FLUSH CVC PORT UNTIL REMOVED ONE-LINK IV CONNECTOR. RECONNECTED TPN TO CVC WITHOUT ONE-LINK IV CONNECTOR. PUMP DID NOT ALARM DOWNSTREAM OCCLUSION.THIS FACILITY HAS HAD MULTIPLE SIMILAR PROBLEMS WITH THIS DEVICE. LINE PATENCY IS CONFIRMED. WHEN THE DEVICE IS IN PLACE, FLUID WILL NOT INFUSE. WHEN THE DEVICE IS REMOVED, FLUID WILL INFUSE WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325327 ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORP. 7N8399 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *
    2 *
    3 *
    4 *
    5 *