BEUDAMED
    FDA Adverse Event Summary report: N

    EZ-IO

    MDR report key: 2222648 · Received July 11, 2011

    Report

    Report Number
    3004526033-2011-00005
    Date Received
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K051992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPARTMENT SYNDROME WAS THE RESULT OF LEAKAGE FROM DISLODGEMENT OR POSSIBLY FROM IMPROPER INSERTION TECHNIQUE. CONFIRMATION OF NEEDLE PLACEMENT IN THE MEDULLARY SPACE IS CRITICAL BEFORE INFUSION OF FLUIDS. THE ARTICLE INDICATED FLUID FLOWED EASILY THROUGH THE IO WHICH IS NOT AN INDICATION THAT THE NEEDLE IS INSERTED PROPERLY. THERE WAS NO INDICATION THAT OTHER TECHNIQUES WERE USED TO DETERMINE IF IO WAS PROPERLY INSERTED. ESTABLISHED GUIDELINES FOR IV AND IO PLACEMENT INDICATE THAT THE LINE MUST BE VERIFIED TO BE PROPERLY PLACED BEFORE INFUSION IS STARTED. APPARENTLY MEDICAL PERSONNEL FAILED TO MONITOR THE LEG FOR EXTRAVASATION DURING THE HOURS PRECEDING THE DISCOVERY OF THE COMPARTMENT SYNDROME WHICH IS ESSENTIAL FOR PREVENTING COMPARTMENT SYNDROME. COMPARTMENT SYNDROME IS A KNOWN COMPLICATION OF INTRAOSSEOUS USE. (B)(4)

    Description of Event or Problem · 1

    EZ-IO INSERTED IN THE RIGHT TIBIA DURING RESUSCITATION. ONE DAY AFTER INSERTION AND FLUID INFUSION, HOSPITAL STAFF NOTICED SWELLING AND ECCHYMOSIS AROUND THE INTRAOSSEOUS NEEDLE INSERTION SITE. INFUSIONS WERE STOPPED. ORTHOPAEDIC ASSESSMENT OF THE PT CONFIRMED COMPARTMENT SYNDROME. FOUR COMPARTMENT FASCIOTOMIES WERE PERFORMED. SEVENTY TWO HOURS AFTER ADMISSION AND WHEN CARDIAC STATUS ALLOWED THE PT WAS AGAIN ASSESSED BY ORTHOPAEDIC PHYSICIAN. EVAL INDICATED FULL THICKNESS SKIN LOSS, SUBCUTANEOUS TISSUE LOSS AND BONY NECROSIS OF THE PROXIMAL TIBIA, SURROUNDING AN AREA CORRESPONDING TO THE ENTRY POINT OF THE CANNULA. THE SOFT TISSUE INJURY WAS IN KEEPING WITH A CHEMICAL INJURY WITH EVIDENCE OF AN EXTRAVASATION INJURY SPREADING FROM THE INSERTION POINT OF THE CANNULA IN THE PROXIMAL TIBIA RADIALLY AND IN AN OUTWARD DIRECTION FROM DEEP TO SUPERFICIAL. MULTIPLE PROCEDURES UNDERTAKEN OVER SEVERAL WEEKS WERE REQUIRED TO STABILIZE THE LEG ALONG WITH SEVERAL COMPLICATIONS FROM THE PROCEDURES. EIGHTEEN MONTHS AFTER THE INITIAL PRESENTATION THERE ARE NOW SIGNS OF SOME BONE BRIDGING BUT HEALING IS NOT COMPLETE. THE OPTION OF BELOW THE KNEE AMPUTATION IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-IO INTRAOSSEOUS NEEDLE SET FMI FMI VIDACARE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| S