BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMINGBIRD DUAL PORT

    MDR report key: 10860070 · Received November 18, 2020

    Report

    Report Number
    10860070
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 6, 2020
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS A DOUBLE LUMEN PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) WITH TPN AND SMOFLIPIDS (LIPID INJECTABLE EMULSION) RUNNING. WHILE DOING PATIENT CARE NOTICED BEDDING WAS WET, ASSESSED LINE AND NOTED FLUID LEAKING AT THE END OF THE HUMMI DEVICE. PAUSED FLUIDS, CLAMPED LINE, AND UNDER STERILE PROCEDURE WITH THE ASSISTANCE OF ANOTHER NURSE REPLACED HUMMI DEVICE AND NOTIFIED THE NNP COVERING THE PATIENT. BROKEN HUMMI DEVICE WAS PLACED IN A BIO HAZARD BAG AND GIVEN TO NIGHT SHIFT MANAGER. REMOVED, WILL SEND TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327089 HUMMINGBIRD DUAL PORT SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC HMD-100-008

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA