BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO

    MDR report key: 3676711 · Received March 4, 2014

    Report

    Report Number
    3004526033-2014-00001
    Event Type
    Injury
    Date Received
    March 4, 2014
    Report Date
    February 28, 2014
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DESCRIPTION OF THE EVENT THE USER MAY HAVE INADVERTENTLY PENETRATED THE CORTEX OF THE BONE WITH AN INITIAL ATTEMPT AT PLACING AN IO IN THE TIBIA. A SECOND ATTEMPT IN THE SAME BONE WAS SUCCESSFUL AND A LARGE VOLUME OF FLUID WAS INFUSED. FLUID MAY HAVE ESCAPED FROM THE DAMAGE CREATED BY THE INITIAL ATTEMPT CAUSING EXTRAVASATION AND SUBSEQUENTLY COMPARTMENT SYNDROME. OUR LAB RESEARCH INDICATES EVEN A SMALL SCRATCH OR DAMAGE TO THE CORTEX OF A BONE CAN RESULT IN EXTRAVASATION OF FLUIDS BEING INFUSED IN THE SAME BONE ESPECIALLY WHEN LARGE VOLUMES ARE BEING INFUSED. THE PRODUCT IFU WARNS AGAINST ATTEMPTING TO INSERT TWO IO NEEDLES IN THE SAME BONE.

    Description of Event or Problem · 1

    THE INFORMATION BELOW WAS OBTAINED DURING VIDACARE'S POST MARKET SURVEILLANCE PROCESS IN THE FOLLOWING (B)(4) LITERATURE: LETTERS TO THE EDITOR / ANNALS FRENCH ANESTHESIA AND INTENSIVE CARE 30 (2011) 86-93. A (B)(6) YEAR OLD OBESE BURN PATIENT INSERTED WITH VIDACARE EZ-IO 15G 25MM LONG NEEDLE SET IN THE RIGHT TIBIA. FIRST ATTEMPT FAILED AND A SECOND ATTEMPT IN THE SAME LEG WAS SUCCESSFUL. TEN HOURS AFTER INSERTION AND DELIVERY OF 4500ML OF FLUIDS THE FOOT OF THE PATIENT APPEARED TO HAVE ACUTE ISCHEMIA, CYANOSIS, COLDNESS AND NO TIBIAL PERIPHERAL PULSE ON EITHER THE POSTERIOR OR DORSAL SIDE OF THE LEG. LEG SHOWED AN INCREASE IN DIAMETER AND ADDITIONAL EDEMA CONSISTENT WITH COMPARTMENT SYNDROME. EMERGENCY FASCIOTOMY WAS PERFORMED AND NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130023 EZ-IO INTRAOSSEOUS NEEDLE SET FMI VIDACARE CORPORATION 25MM IO NEEDLE SET

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention