BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVIZION ENTERAL FEEDING TUBE

    MDR report key: 10261894 · Received July 12, 2020

    Report

    Report Number
    3011548489-2020-00001
    Event Type
    Injury
    Date Received
    July 12, 2020
    Date of Event
    April 26, 2020
    Report Date
    May 25, 2020
    Manufacturer
    ENVIZION MEDICAL, LTD.
    Product Code
    KNT
    PMA / PMN Number
    K191387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE CLINICIAN DID PROVIDE THE FILES FROM THE SYSTEM. THE ENVUE SYSTEM PLACEMENT HISTORY WAS REVIEWED AND CONFIRMED THE ABOVE DESCRIPTION OF THE EVENTS DESCRIBED BY THE CLINICIAN. IN REVIEWING THE PLACEMENT HISTORY, THE SECOND FEEDING TUBE WAS PLACED ON (B)(6) 2020. IN TOTAL, THERE WERE TWO PLACEMENT ATTEMPTS ON (B)(6) 2020. ON THE FIRST ATTEMPT, WHILE INSERTING THE FEEDING TUBE, A RED ARROW APPEARED IN THE UPPER RIGHT QUADRANT OF THE FRONTAL VIEW, REPRESENTING A PLACEMENT INTO THE RIGHT BRONCHUS. THE RED ARROW CONTINUED TO APPEAR AS THE TUBE WAS ADVANCED FURTHER. THE TUBE WAS THEN RETRACTED AND RE-ADVANCED INTO THE LEFT BRONCHUS WHILE A RED ARROW CONTINUOUSLY APPEARED IN THE UPPER LEFT QUADRANT. AT THE SAME TIME, THE LATERAL VIEW DEMONSTRATED A DIRECT DROP OF THE PATHWAY WITH NO ASCENT INTO THE STOMACH. WHEN FEEDING TUBE TIP REACHED THE XIPHOID PROCESS ON FRONTAL VIEW, THE FEEDING TUBE PATHWAY DID NOT DEMONSTRATE ASCENT ON THE LATERAL VIEW AND NO PATHWAY WAS CREATED ON AXIAL VIEW BOTH PROVIDING ADDITIONAL INDICATION FOR POTENTIAL LUNG PLACEMENT. ON THE SECOND ATTEMPT, WHILE INSERTING THE FEEDING TUBE, A RED ARROW APPEARED IN THE UPPER LEFT QUADRANT OF THE FRONTAL VIEW, REPRESENTING A PLACEMENT INTO THE LEFT BRONCHUS. THEREAFTER, A DIRECT DROP WAS DISPLAYED ON THE LATERAL VIEW WITH NO ASCENT INTO THE STOMACH. WHEN FEEDING TUBE TIP REACHED THE XIPHOID PROCESS ON FRONTAL VIEW, THE FEEDING TUBE PATHWAY DID NOT DEMONSTRATE ASCENT ON THE LATERAL VIEW AND NO PATHWAY WAS CREATED ON AXIAL VIEW BOTH PROVIDING ADDITIONAL INDICATIONS FOR A POTENTIAL LUNG PLACEMENT. A REVIEW OF THE TRAINING MATERIALS, THE USER MANUAL AND THE INSTRUCTIONS WAS PERFORMED. THE SYSTEM INDICATORS FOR POTENTIAL LUNG PLACEMENT ARE DESCRIBED AND THE LABELING PROVIDES A WARNING: "THE ENTERAL FEEDING TUBE POSITION MUST BE CONFIRMED PER INSTITUTION PROTOCOL (I.E. X-RAY, PH MEASUREMENT, ETC.)." IN REVIEWING THE ENTERAL FEEDING TUBE IFU, IT STATES THE FOLLOWING: "IF PATHWAY OF THE TUBE ON THE DISPLAY SHOWS A SEVERE CURVE TO THE RIGHT OR LEFT ABOVE THE XIPHOID PROCESS ANATOMICAL LANDMARK, (SEE FIGURES 1-2) IMMEDIATELY PULL BACK ON FEEDING TUBE AND ADJUST PLACEMENT TO SHOW A STRAIGHT LINE TOWARDS THE HORIZONTAL AXIS." IN REVIEWING THE ENVUE SYSTEM USER MANUAL, THE MANUAL STATES THE FOLLOWING: "THE SYSTEM ALSO INDICATES THE CURRENT POSITION OF THE FEEDING TUBE TIP IN THE FRONTAL VIEW BY A YELLOW CROSSHAIR (+) SYMBOL AND THE TIP DIRECTION BY A WHITE ARROW SYMBOL IN FRONT OF THE PATHWAY. WHEN THE ARROW SYMBOL IS IN THE UPPER TWO QUADRANTS AND ITS DIRECTION DEVIATES FROM THE CENTER LINE CONNECTING THE TWO FIDUCIAL POINTS, THE COLOR OF THE ARROW CHANGES FROM WHITE TO RED." ALSO, IN THE USER MANUAL THE FOLLOWING INSTRUCTIONS, WARNINGS AND CAUTIONS ARE INCLUDED; "AS YOU SLOWLY INSERT THE TUBE, ENVUE WILL SHOW YOU IMMEDIATE UPDATES OF THE POSITION OF THE FEEDING TUBE TIP ONCE IT ENTERS THE SENSING VOLUME." WARNING: "ONLY CLINICAL PERSONNEL FAMILIAR WITH THE PLACEMENT OF ORO/NASOENTERIC TUBES SHOULD PERFORM TUBE PLACEMENTS." WARNING: "DO NOT PUSH FORWARD WITHOUT LOOKING AT THE SCREEN OR WITHOUT AN IMAGE FROM THE DISPLAY. IF THE ENVUE SYSTEM IS NOT AVAILABLE, REVERT TO STANDARD OF CARE FOR MANUAL FEEDING TUBE PLACEMENTS FOLLOWED BY CONFIRMATION OF TUBE PLACEMENT PER INSTITUTION PROTOCOL." CAUTION: "IT IS NECESSARY TO UNDERSTAND THE FRONTAL, LATERAL AND AXIAL INDICATIONS PROVIDED BY THE DISPLAY DURING THE PLACEMENT PROCEDURE. ENSURE THAT THE SYSTEM IS ONLY USED BY A TRAINED PERSON FAMILIAR WITH ALL SYSTEM OPERATING PROCEDURES. INSTITUTION PERSONNEL SHOULD COMPLETE A TRAINING PROGRAM PRIOR TO OPERATING THE ENVUE SYSTEM." IN REVIEWING THE ENVUE SYSTEM TRAINING MATERIALS: THE PRESENTATION INSTRUCTS THE USERS THAT WHEN THE ARROW SYMBOL TURNS RED; THIS IS INDICATING A POSSIBLE INSERTION INTO BRONCHIAL AIRWAYS. THIS IS ALSO COVERED IN THE TRAINING OUTLINE - WHEN RED ARROW APPEARS: EXPLAIN THIS IS A WARNING THAT YOU COULD BE HEADING INTO THE AIRWAYS (DEVIATION FROM MIDLINE) AND YOU SHOULD STOP PROCEDURE, CLINICALLY EVALUATE AND PROCEED WITH CAUTION. CONCLUSIONS: SYSTEM HARDWARE AND SOFTWARE FUNCTIONED PROPERLY IN ALL 4 PROCEDURES THE FIRST ATTEMPT ON (B)(6) 2020 MOST PROBABLY CAUSED THE PNEUMOTHORAX EVENT GIVEN THE CHARGE NURSE OBSERVED THAT THE PATIENT HAD ALREADY DEVELOPED RESPIRATORY DISTRESS WITH A BREATHING RATE OF 30/MIN. THE PNEUMOTHORAX WAS CAUSED DUE TO THE FOLLOWING REASONS: USERS DID NOT TAKE INTO CONSIDERATION THE ILLUMINATION OF THE BLINKING RED ARROW AND THE LATERAL VIEW THAT PROVIDES INFORMATION REGARDING THE DESCENT AND ASCENT OF THE ESOPHAGUS AND ENTRANCE INTO THE GI AREA. THE SENSE OF URGENCY OF PROVIDING PATIENT MEDICATION MAY HAVE CONTRIBUTED TO THE USE ERROR FINAL CONCLUSION THE DEVICE PERFORMED AS EXPECTED AND THE PNEUMOTHORAX WAS DUE TO USE ERROR. LATE MDR FILING: THE EMDR FILE WAS READY TO SUBMIT WITHIN THE 30 DAY TIMEFRAME BUT WAS UNABLE TO ELECTRONICALLY SUBMIT TO THE GATEWAY. ESTABLISHING THE GATEWAY TOOK ADDITIONAL TIME WHICH HAS CAUSED THE LATE FILING.

    Description of Event or Problem · 1

    (B)(6)-YEAR FEMALE, POST MOTOR VEHICLE ACCIDENT, WAS HOSPITALIZED DUE TO MULTIPLE BONE FRACTURES INCLUDING RIGHT SIDED RIB FRACTURES THAT CAUSED A HEMOTHORAX. A RIGHT CHEST TUBE WAS INSERTED. THE PATIENT WAS INTUBATED INITIALLY. AFTERWARDS THE PATIENT RECEIVED A NASAL CANNULAR FOR ASSISTANCE IN BREATHING. AN ENVUE FEEDING TUBE WAS INSERTED ON (B)(6) 2020 AND WAS PLACED POST-PYLORICALLY. THE PATIENT INDEPENDENTLY REMOVED THE FEEDING ON (B)(6) 2020. A REQUEST FOR A NEW ENVUE FEEDING TUBE WAS REQUESTED AT 8:30 AM ON (B)(6) 2020. THE FEEDING TUBE WAS PLACED BY THE CLINICIAN AT APPROXIMATELY 10 AM. AFTER THE INITIAL INSERTION ATTEMPTS THE CLINICIAN REQUESTED FROM THE CHARGE NURSE FOR ASSISTANCE AND STATED "I AM HAVING A TOUGH TIME AS THE TUBE WANTS TO GO INTO THE LUNG". THE CHARGE NURSE BEGAN ASSISTING THE CLINICIAN AND ASSESSED THE PATIENT. THE CHARGE NURSE OBSERVED THAT THE RESPIRATORY STATUS OF THE PATIENT WAS NOT SATISFACTORY AS THERE WAS A SHORTNESS OF BREATH AND A BREATH RATE OF 30 BPM. THE CHARGE NURSE DECIDED TO PERFORM A NEW SETUP AND REGISTRATION USING THE ENVUE SYSTEM WHICH WAS COMPLETED CORRECTLY AND ACCURATELY. DURING THE REGISTRATION PROCESS, THE CLINICIAN STRESSED TO THE CHARGE NURSE THE PATIENT MUST RECEIVE A FEEDING TUBE AS THE PATIENT REQUIRED MEDICATION FOR HER HYPERTENSION. THE CHARGE NURSE STARTED A NEW TUBE PLACEMENT USING THE ENVUE SYSTEM AND INSERTED THE ENVUE FEEDING TUBE INTO THE RIGHT NARE AND PUSHED THE FEEDING TUBE FORWARD. THE SYSTEM DISPLAYED DIRECTION INDICATOR ARROW BEGAN BLINKING RED WHICH INDICATES A DEPARTURE FROM THE CENTER LINE IN THE ESOPHAGEAL PATHWAY WHICH INDICATES A POTENTIAL LUNG PLACEMENT. THE CHARGE NURSE REMOVED THE FEEDING TUBE AND BEGAN A SECOND ATTEMPT AT A NEW PLACEMENT VIA THE RIGHT NARE. AFTER PUSHING THE FEEDING TUBE FORWARDS THE WHITE ARROW STARTED BLINKING RED AGAIN. ALTHOUGH THE ENVUE SYSTEM WAS INDICATING A POSSIBLE LUNG PLACEMENT, THE CHARGE NURSE DECIDED TO CONTINUE TO PUSH FORWARDS UNTIL THE AREA OF THE STOMACH AS REQUESTED BY THE CLINICIAN WHO REEMPHASIZED AGAIN THE NECESSITY OF PLACING THE TUBE IN THE STOMACH FOR MEDICATION ACCESS. THE FEEDING TUBE WAS SECURED PER STANDARD OPERATING PROCEDURE. APPROXIMATELY 20 MINUTES POST PLACEMENT THE PATIENT DEVELOPED SYMPTOMS OF ADDITIONAL RESPIRATORY DISTRESS. A CHEST X-RAY DEMONSTRATED A LEFT LUNG PNEUMOTHORAX. THE FEEDING TUBE WAS REMOVED AND A PIGTAIL CATHETER FOR DRAINAGE WAS PLACED. IT WAS LATER REPLACED WITH A LARGER FRENCH CHEST TUBE. THE PATIENT STABILIZED IMMEDIATELY. ON (B)(6) 2020 THE PATIENT WAS DISCHARGED FROM THE TRAUMA ICU. THE CHARGE NURSE COMMENTED THAT "THE TECHNOLOGY TRIED TO STOP ME AND I DID NOT LISTEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726302 ENVIZION ENTERAL FEEDING TUBE ENTERAL FEEDING TUBE KNT ENVIZION MEDICAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention