BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-IO POWER DRIVER

    MDR report key: 10066064 · Received May 18, 2020

    Report

    Report Number
    3011137372-2020-00108
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 24, 2020
    Report Date
    April 27, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FMI
    PMA / PMN Number
    K180395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE MANUFACTURING DHR FILE WAS REVIEWED. NO RECORDED RESULTS OF MANUFACTURING ISSUES OR ANOMALIES WERE REPORTED. EZ-IO DRIVER 9058 (SN(B)(6) ) WAS RETURNED FOR EVALUATION. UPON RECEIPT, THE DRIVER WAS VISUALLY INSPECTED. NO OBVIOUS SIGNS OF DAMAGE WERE OBSERVED. WHEN THE TRIGGER WAS PULLED THE DRIVER WAS OPERABLE AND A SOLID GREEN LED LIGHT WAS DISPLAYING. THE DRIVER WAS THEN SUBJECTED TO SIMULATED SAWBONE INSERTIONS. THIS FUNCTIONAL TEST IS USED TO DETERMINE WHETHER THE RETURNED DEVICE STILL HAS THE CAPABILITY TO POWER A 45MM EZ-IO NEEDLE SET INTO A MEDIUM AND/OR HARD BONE. THE 45MM EZ-IO NEEDLE SET IS USED BECAUSE IT REPRESENTS THE WORST-CASE SCENARIO FOR IO INSERTION. TWO (2) SAWBONES WITH MEDIUM (50 LBS/FT3) AND HARD (105 LBS/FT3) HARDNESS PROFILES WITH 3MM CORTEXES WERE USED FOR THE TEST. EACH INSERTION WAS TIMED WITH A STOPWATCH (ID: C05180) WHILE APPLYING APPROXIMATELY 8 LBS. OF FORCE ON A WEIGHT SCALE (ID: C05318). APPROXIMATELY (B)(4) TO (B)(4) LBS. OF FORCE IS NECESSARY TO PENETRATE BONE. BELOW ARE THE TEST RESULTS: MEDIUM PROFILE (50 LBS/FT3) INSERTION 1: 3.05 INSERTION 2: 2.95 INSERTION 3: 2.86 HARD PROFILE (105 LBS/FT3) INSERTION 1: 5.29 INSERTION 2: 5.60 INSERTION 3: 5.73 THE DRIVER SUCCESSFULLY NEGOTIATED BOTH THE SOFT AND HARD SAW BONE INSERTION TESTING. THE COMPLAINT CANNOT BE CONFIRMED. SEVERAL SECTIONS OF THE IFU WILL BE REFERENCED AS PART OF THIS INVESTIGATION REPORT. THE IFU STATES, "AS WITH ANY EMERGENCY MEDICAL DEVICE CARRYING A BACKUP IS STRONGLY ADVISED PROTOCOL", "EZ-IO POWER DRIVER LED WITH BLINK RED WHEN THE TRIGGER IS ACTIVATED AND HAS ONLY 10% OF BATTERY LIFE REMAINING", AND "PURCHASE AND REPLACE THE EZ-IO POWER DRIVER WHEN THE RED LED BEGINS BLINKING". A REVIEW OF THE DHR FOUND THAT THE DRIVER PASSED ALL THE RELEASE CRITERIA. THE DEVICE WAS RELEASED IN (B)(6)2019 AND IS APPROXIMATELY (B)(4) YEAR OLD. THE COMPLAINT CANNOT BE CONFIRMED. FUNCTIONAL TESTING HAS CONFIRMED NO FAULT FOUND WITH THIS DRIVER. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE ASSIGNED. FUNCTIONAL TESTING HAS CONFIRMED NO FAULT FOUND WITH THIS DRIVER. NO FURTHER ACTION REQUIRED. AT THE CONCLUSION OF TESTING THE SOLID GREEN STATUS LIGHT WAS STILL ACTIVE.

    Description of Event or Problem · 0

    THE REPORT STATES: I HAVE AN EZ IO DRIVER, S/N (B)(6) , WHICH WAS PURCHASED ON PO'55386, IN (B)(6)2020 , THAT THE CREWS REPORTED THAT IT DID NOT HAVE ENOUGH TORQUE. IT BOGGED DOWN ON (B)(4) DIFFERENT ATTEMPTS (THEY BENT (B)(4) IO NEEDLES IN THE PROCESS). ANOTHER DRIVER WAS USED SUCCESSFULLY. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT IS REPORTED TO BE DECEASED. ACCORDING TO THE REPORT FORM THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE DEATH OF THE PATIENT PER THE EMT-P.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: I HAVE AN EZ IO DRIVER, S/N (B)(4), WHICH WAS PURCHASED ON (B)(6), IN (B)(6)2020, THAT THE CREWS REPORTED THAT IT DID NOT HAVE ENOUGH TORQUE. IT BOGGED DOWN ON 4 DIFFERENT ATTEMPTS (THEY BENT 4 IO NEEDLES IN THE PROCESS). ANOTHER DRIVER WAS USED SUCCESSFULLY. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT IS REPORTED TO BE DECEASED. ACCORDING TO THE REPORT FORM THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE DEATH OF THE PATIENT PER THE EMT-P.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529712 EZ-IO POWER DRIVER NEEDLE, HYPODERMIC, SINGLE LU FMI TELEFLEX MEDICAL 134831

    Patients

    Seq Age Sex Outcome Treatment
    1