BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 21490904 · Received February 28, 2025

    Report

    Report Number
    21490904
    Event Type
    Death
    Date Received
    February 28, 2025
    Date of Event
    December 15, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN INFANT ADMITTED TO NICU AND UMBILICAL ARTERIAL (UAC) AND UMBILICAL VENOUS CATHETERS (UVC) WERE TO BE PLACED. PRIOR TO PLACEMENT, THE UAC AND UVC LINES WERE SPIKED AND HANGING IN THE IV PUMPS. THE PHYSICIAN INSERTED THE UAC AND UVC WITH ASSISTANCE FROM THE RN. FOLLOWING THE DRAWING OF 2 SETS OF LABS AND A X-RAY, THE LINES WERE CONNECTED TO UAC AND UVC. SHORTLY AFTER, THE RN NOTICED THE BEDSIDE MONITOR WENT BLANK AND THE RN BEGAN TO TROUBLESHOOT. THE RN NOTICED THE INFANT WAS VERY PALE WITH SHALLOW CHEST RISE. IMMEDIATELY, THE RN CALLED FOR ASSISTANCE AND INFANT ARRESTED. THE PHYSICIAN NOTICED AIR IN THE UAC TUBING. PROMPTLY, THE RN STOPPED THE LINE AND REMOVED THE AIR. THE PHYSICIAN WAS ABLE TO VISUALIZE AIR ON THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608107 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 2426-0007 24109078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Death