BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE LINK NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLAC

    MDR report key: 3893475 · Received June 13, 2014

    Report

    Report Number
    3893475
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A TWO-LUMEN HANDSFREE CATHETER PLACED THROUGH AN EXISTING INTRODUCER. ATTEMPTED TO RUN Y SITE OF VASO AND HEPARIN THROUGH ONE OF THESE NEW LUMENS. BOTH PUMPS HAD DOWNSTREAM OCCLUSION ALARMS. FLUSHED LUMEN THROUGH THE ONELINK WITH 10CC NS AND IT FLUSHED EASILY. WHEN ATTACHED THE Y SITE, DOWNSTREAM OCCLUSION OCCURRED. PUMPS WORKED CORRECTLY WHEN THE ONELINK WAS REMOVED.THIS FACILITY HAS HAD MULTIPLE SIMILAR PROBLEMS WITH THE ONE-LINK DEVICE. STAFF REPEATEDLY HAVE CONFIRMED THAT THE LINES IN THESE CASES ARE OPEN/FUNCTIONING AND THAT PUMPS ARE FUNCTIONING. WHEN THE ONE-LINK IS IN PLACE, THE LINE WILL NOT FLUSH OR THE PUMP WILL ALARM. WHEN THE DEVICE IS REMOVED, THE INFUSION/FLUSH IS GIVEN WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351227 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 28 YR