BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL

    MDR report key: 15707799 · Received November 1, 2022

    Report

    Report Number
    15707799
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 7, 2022
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A LEFT INTERNAL JUGULAR LINE WITH TRIPLE LUMEN PORTS PLACED FOR IV INFUSION. THE IV TUBING WAS CONNECTED TO THE DEVICE CALLED MICROCLAVE CLEAR CONNECTOR THAT SEALS WITH SILICONE WHEN NOT IN USE. TWO DAYS LATER, THE PATIENT WAS DIAGNOSED WITH BILATERAL HEMISPHERIC STROKES DUE TO AIR EMBOLI. AFTER THE EVENT, IT WAS DISCOVERED THAT ONE OF THE TUBING CONNECTORS FAILED TO SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639537 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 12512-01

    Patients

    Seq Age Sex Outcome Treatment
    1 11680 DA Male Life Threatening| R