BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO

    MDR report key: 18169692 · Received November 20, 2023

    Report

    Report Number
    18169692
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    July 22, 2023
    Report Date
    September 26, 2023
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE DOING CENTRAL LINE AUDITS ON [REDACTED DATE] AT 0400, NOTED THE BAXTER TUBING INFUSING TPN INTO CENTRAL PICC LINE WAS LEAKING FROM THE Y-SITE (SECOND SITE DOWN FROM THE BAG). NOTIFIED BEDSIDE RN AND APP, NEW FLUIDS ORDERED, AND TUBING CHANGED PER PROTOCOL. LEAKING TUBING SAVED IN Q S OFFICE AND Y-SITE LABELED. MANUFACTURER RESPONSE FOR IV TUBING, IV TUBING (PER SITE REPORTER), ONGOING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854993 CLEARLINK/CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL INC. 2R8546 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown