BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 14840872 · Received June 28, 2022

    Report

    Report Number
    14840872
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 17, 2022
    Manufacturer
    ICU MEDICAL, 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

    RN AT BEDSIDE TO DISCONTINUE MORPHINE PCA PER ORDERS. POOL OF BLOOD NOTED ON FLOOR, BLOOD AND FLUID DRIPPING FROM IV PUMPS. LINES BLOOD TINGED DUE TO APPARENT BACKFLOW. LINES IMMEDIATELY CLAMPED AND INFUSIONS STOPPED, CHARGE NURSE CALLED INTO ROOM. NO BLOOD APPEARED TO BE DRIPPING FROM PATIENT PIV. BLOOD AND FLUID APPEARED TO BE DRIPPING AROUND WHERE THE PCA TUBING WAS "Y-ED" INTO THE MAINTENANCE FLUID TUBING - POSSIBLE CRACK IN CAP OR HOLE IN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750042 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. 21-792-24

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown