BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO

    MDR report key: 19339699 · Received May 17, 2024

    Report

    Report Number
    19339699
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 24, 2024
    Report Date
    April 25, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BAXTER TUBING INFUSING TPN NOTED TO BE LEAKING AT Y-SITE WITH GREEN ALCOHOL CAP IN PLACE. A NEW CAP WAS APPLIED BUT LEAKING CONTINUED. MEDICAL TEAM NOTIFIED. NEW FLUIDS ORDERED. BUT INFANT WILL MISS AT LEAST 6 HOURS OF TPN AND SMOF (THE SOYBEAN OIL, MEDIUM-CHAIN TRIGLYCERIDES, OLIVE OIL, AND FISH OIL) LIPIDS NOW WHICH IS ESSENTIAL NUTRITION FOR THIS BABY. ESPECIALLY SINCE HE IS NPO (NOTHING BY MOUTH) AND RECOVERING FROM NEC/SIP (NECROTIZING ENTEROCOLITIS/SPONTANEOUS INTESTINAL PERFORATION). MANUFACTURER RESPONSE FOR IV TUBING, (BRAND NOT PROVIDED) (PER SITE REPORTER) NOTIFIED [REDACTED DATE] VIA EMAIL WITH PLAN FOR INTERNAL TESTING. MEETING WEEKLY TO REVIEW NEW LEAKING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2535810 CLEARLINK/CONTINU-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER INTERNATIONAL INC. 2R8546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other