BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION

    MDR report key: 2021716 · Received March 14, 2011

    Report

    Report Number
    MW5019796
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    January 4, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BAXTER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) TERM BABY WITH RESPIRATORY DISTRESS IN 40% OXYHOOD NPO WITH D10W. RN DISCONNECTED MEDICATION GENTAMYCIN TUBING AND TUBING SLID OFF RADIANT WARMER. RN NOTICED BLOOD BACKING UP IN TUBING AND FOUND TUBING HAD COME APART WHERE DOUBLE LUMEN JOINS INTO THE Y JUNCTURE. IV CLAMPED REMOVED FROM PT. A FEW DROPS OF BLOOD WERE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INTERLINK SYSTEM NON DEHP THREE LEAD EXTENSION LEAD EXTENSION SET FPA BAXTER 2N3341 ORIGINAL PACKAGE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 8 HR Life Threatening