BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDACARE EZ-IO INTRAOSSEOUS ACCESS DEVICE

    MDR report key: 3936054 · Received June 23, 2014

    Report

    Report Number
    3004526033-2014-00007
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    June 18, 2014
    Manufacturer
    VIDACARE LLC
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF SERIOUS IO-NEEDLE COMPLICATION IS EXTREMELY RARE. IN THIS CASE, SEVERAL PREDISPOSING FACTORS WERE FOUND: RESUSCITATION EPISODE ITSELF. HIGH-DOSE INOTROPE INFUSIONS ADMINISTRATION, THERAPEUTIC HYPOTHERMIA FOR 24 HOURS AND THE ARTERIAL CATHETER IN THE RIGHT FEMORAL ARTERY. EXTRAVASATION IS A KNOWN COMPLICATION OF ANY FORM OF VASCULAR ACCESS. ADMINISTRATION OF VESICANT, TOXIC, OR HIGHLY-CONCENTRATED DRUGS REQUIRES EXTREME CAUTION AND CONFIRMATION OF PATENCY OF ANY TYPE OF VASCULAR ACCESS ROUTE BEFORE ADMINISTRATION.

    Description of Event or Problem · 1

    PREVIOUSLY HEALTHY FULL TERM (B)(6) OLD, PRESENTED TO THE ER OF (B)(6) HOSPITAL. SHORTLY AFTER ER ADMISSION, THE BABY WENT UNCONSCIOUS AND STOPPED BREATHING. THERE WAS A BRIEF EPISODE OF SUPRAVENTRICULAR TACHYCARDIA WHICH TURNED INTO BRIEF VENTRICULAR TACHYCARDIA BEFORE PULSELESS ELECTRICAL ACTIVITY. RESUSCITATION WAS IMMEDIATELY STARTED BY PEDIATRIC AND ANESTHESIA ATTENDING'S. AN INTRAOSSEOUS VASCULAR ACCESS WAS ACHIEVED VIA A 15MM EZ-IO PLACED INTO LEFT PROXIMAL TIBIA. EXTRAVASATION OCCURRED IMMEDIATELY AND THE NEEDLE WAS REMOVED. ANOTHER 15MM EZ-IO NEEDLE WAS PLACED INTO LEFT DISTAL HEAD OF THE FEMUR. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AFTER 18 MINUTES OF CPR. THE FEMORAL IO-ACCESS WAS DISCONTINUED AFTER MOTION FROM THE PATIENT DISLODGED THE NEEDLE SET. A THIRD 15 MM EZ-IO WAS PLACED IN THE RIGHT TIBIA. PATIENT WAS TRANSFERRED INTO PEDIATRIC INTENSIVE CARE UNIT WHERE THE PATIENT WAS INTUBATED, VENTILATED AND EPINEPHRINE INFUSION WAS ADMINISTERED INTO THE IO-NEEDLE. THERAPEUTIC HYPOTHERMIA (32-34 DEGREE CELSIUS) WAS INITIATED FOR 24 HOURS. SEVERAL ATTEMPTS TO PLACE A FEMORAL CENTRAL LINE WAS TRIED WITHOUT SUCCESS. BECAUSE OF INABILITY TO FIND ADDITIONAL VASCULAR ACCESS CONTINUOUS EPINEPHRINE -INFUSION 0,15 UG/KG/MIN AND NOREPINEPHRINE - INFUSION 0,1 UG/KG/MIN WAS ADMINISTERED INTO IO- NEEDLE INSTEAD OF PERIPHERAL VEIN CATHETERS. AFTER 24 HOUR OF THERAPEUTIC HYPOTHERMIA, THE PATIENT WAS SLOWLY WARMED DURING THE NEXT 12 HOURS. A SERIOUS COMPLICATION OF THE RIGHT LOWER LIMB WAS NOTICED 24 HOURS AFTER PLACEMENT OF THE IO- NEEDLE. THE LIMB WAS COLD AND PALE WITH A CLEAR DEMARCATION LINE BELOW THE IO-NEEDLE INSERTION. THE IO- NEEDLE WAS REMOVED. A CENTRAL VENOUS LINE WAS PLACED INTO RIGHT FEMORAL VEIN. TWO DAYS AFTER THE PLACEMENT OF THE IO-NEEDLE, THERE WAS EPIDERMOLYSIS OF THE SKIN OF THE RIGHT DISTAL LIMB. AN ANGIOGRAPHY AND SEVERAL FASCIOTOMIES OF THE RIGHT LIMB MUSCLES WERE PERFORMED. ON DAY 5, THE SECOND OPERATION ALL LOWER LIMB COMPARTMENTS WERE NON-VIABLE AND AN AMPUTATION WAS MADE BELOW THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367066 VIDACARE EZ-IO INTRAOSSEOUS ACCESS DEVICE INTRAOSSEOUS ACCESS DEVICE FMI VIDACARE LLC 9018

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DA Required Intervention| S