BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO

    MDR report key: 3676697 · Received March 4, 2014

    Report

    Report Number
    3004526033-2014-00002
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    November 24, 2013
    Report Date
    February 28, 2014
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K051992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT MADE VIA EMAIL TO VIDACARE SALES REPRESENTATIVE OF POSSIBLE GANGRENE IN INFANT RESUSCITATED IN THE ED OF (B)(6) HOSPITAL. UPON RECEIPT OF THE FORWARDED EMAIL, CONTACT BY EMAIL AND PHONE WAS MADE WITH (B)(6), THE REPORTING NURSE. SHE INDICATED ON PHONE SHE HAD HEARD ABOUT THE PT BUT SHE WOULD FIND OUT FURTHER AS PT DIED UNRELATED TO THE LEG INJURY AND (B)(6) WAS NOT SURE ABOUT NEED TO REPORT. VIDACARE ((B)(4) RN) RESPONDED AND PROVIDED LINK TO FDA.GOV WEBSITE FOR INFORMATION ON REPORTING REQUIREMENTS FOR MANUFACTURERS, SO THE HOSPITAL WOULD FEEL COMFORTABLE AND UNDERSTAND NEED TO SHARE THE BASIC INCIDENT INFORMATION. ON (B)(6), (B)(6) SENT EMAIL CONFIRMING SHE SENT INFORMATION TO THEIR DIRECTOR OF PT SAFETY TO REPORT FINDINGS WITH THE EXPLANATION, THERE WOULD BE A DELAY DUE TO HOLIDAYS. ON (B)(6), (B)(6) SENT EMAIL REPORTING STAFF FELT PROBLEM WAS A VASCULAR ISSUE. ON (B)(6) 2014 AN EMAIL REMINDER WAS SENT TO (B)(6). ON (B)(6) 2014 ANOTHER EMAIL WAS SENT TO (B)(6) AND CALL ATTEMPTED TO PT SAFETY. ON (B)(4) 2014 AN EMAIL WAS RECEIVED FROM (B)(6) WITH PARTIAL DETAILS OF PT INCIDENT. ON (B)(6) 2014 ATTEMPT MADE FOR FURTHER INFORMATION BUT (B)(6) REPORTED SHE WAS TOO BUSY TO RESPOND. DELAY IN REPORTING SECONDARY TO REPEATED ATTEMPTS TO OBTAIN INCIDENT HISTORY.

    Description of Event or Problem · 1

    (B)(6) OLD FEMALE WITH HISTORY OF CONGENITAL CARDIAC ANOMALIES INCLUDING HPLH PRESENTED TO THE ED IN CARDIAC ARREST/CARDIOGENIC SHOCK (B)(6) 2013. CPR WAS IN PROGRESS. AT APPROXIMATELY 0800 MULTIPLE VASCULAR ACCESS ATTEMPTS WERE MADE INCLUDING TWO INTRAOSSEOUS (IO) ACCESS PLACEMENT. AN IO CATHETER IN THE RIGHT LEG DID NOT FLUSH, WAS IMMEDIATELY DISCONTINUED. A 15G CATHETER PLACED TO PT TIBIA SUCCESSFULLY. EPINEPHRINE, CALCIUM AND NORMAL SALINE GIVEN WITH RETURN OF SPONTANEOUS CIRCULATION. NO SIGHS OF INFILTRATION, DISLODGEMENT OR INABILITY TO FLOW NOTED TO IO ACCESS SITE. A CENTRAL LINE WAS INSERTED AND IO DISCONTINUED AT APPROXIMATELY 1100. OVER THE NEXT 12 HOURS, THE LEFT LEG BECAME BLANCHED WITH A RASH, UNABLE TO FEEL PEDAL PULSES, NO CAPILLARY REFILL. LEFT FOOT ISCHEMIA AND NECROSIS NOTED. PLASTIC SURGEON AND VASCULAR PHYSICIAN EVALUATED PT AND DIAGNOSED LEFT LOWER EXTREMITY COMPLETE OCCLUSIVE ARTERIAL AND VENOUS CLOT AS WELL AS RIGHT POPLITEAL NON-OCCLUSIVE VENOUS CLOT. PT WAS PLACED ON HEPARIN INFUSION. NO OBVIOUS SIGNS OF INFECTION NOTED. VASCULAR SURGERY RECOMMENDED ABOVE KNEE AMPUTATION WHEN PT STABILIZED. THE PT DIED A FEW WEEKS LATER UNRELATED TO LEG INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130439 EZ-IO INTRAOSSEOUS NEEDLE SET FMI VIDACARE CORPORATION 15MM IO NEEDLE SET

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Other