BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 17408947 · Received July 27, 2023

    Report

    Report Number
    3011270181-2023-00115
    Event Type
    Death
    Date Received
    July 27, 2023
    Date of Event
    July 5, 2023
    Report Date
    January 9, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR SERIAL NUMBER FOR MU1301046 AND RU21050412 WERE REVIEWED AND THE PRODUCT WERE PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE CUSTOMER PROVIDED THE TRACING OF THE REPORTED INCIDENT. THE CORVIEW CROSS-FUNCTIONAL TEAM THEN REVIEWED THE TRACING. BASED ON THE TRACING PROVIDED, THE CROSS-FUNCTIONAL TEAM DETERMINED THAT THE MONITOR UNIT SCREEN DID SHOW THAT THIS TRACING DID NOT FOLLOW THE EXPECTED PATHWAY OF A TYPICAL GASTRIC PLACEMENT IN ANY VIEW (ANTERIOR, LATERAL, AND DEPTH CROSS-SECTIONAL). THERE ARE MULTIPLE ARTIFACTS LEFT ON THE CORTRAK DISPLAY SCREEN DURING THE PLACEMENT PROCEDURE FROM THE TRACING PROVIDED. THE CORTRAK 2 EAS OPERATOR¿S MANUAL STATES UNDER ¿DURING THE PLACEMENT¿ SECTION THAT ¿ERASE THE RELEVANT PART OF THE PREVIOUS TRACK IF THE TRANSMITTING STYLET IS PULLED BACKWARDS SLOWLY.¿ ARTIFACTS ON SCREEN ARE ALSO DISCUSSED IN CORTRAK 2 EAS OPERATING AND TROUBLESHOOTING TIPS IFU. THEREFORE, BASED ON INSTRUCTIONS FOR USE AND CORVIEW CROSS-FUNCTIONAL REVIEW NOTING THAT TRACING DID NOT SHOW TYPICAL PLACEMENT PATTERN AND THERE WERE MULTIPLE ARTIFACTS ON SCREEN, THE ROOT CAUSE WAS DETERMINED TO BE USER: INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 09 JAN 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H4 APPROPRIATE TERM/CODE NOT AVAILABLE: USAGE PROBLEM IDENTIFIED THE DEVICE HISTORY RECORD FOR LOT 1310001 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER PROVIDED THE TRACING OF THE REPORTED INCIDENT. THE CORVIEW CROSS-FUNCTIONAL TEAM THEN REVIEWED THE TRACING; SEE BELOW FOR SUMMARY OF TRACING FINDINGS: BASED ON THE TRACING PROVIDED, THE CROSS-FUNCTIONAL TEAM DETERMINED THAT THE MONITOR UNIT SCREEN DID SHOW THAT THIS TRACING DID NOT FOLLOW THE EXPECTED PATHWAY OF A TYPICAL GASTRIC PLACEMENT IN ANY VIEW (ANTERIOR, LATERAL, AND DEPTH CROSS-SECTIONAL). ADDITIONALLY, THE PLACEMENT ENDS WITH A GREEN DOT ON THE SCREEN. THE GREEN DOT INDICATES THAT THE OPERATOR DID NOT FOLLOW INSTRUCTIONS FOR USE TO END TRACING PRIOR TO REMOVAL OF STYLET. THERE WERE ALSO INDICATIONS THAT THE OPERATOR HAD DIFFICULTY MOVING TUBE TIP FORWARD AS THE GREEN BALL MOVES BACK AND FORTH IN SAME LOCATION MULTIPLE TIMES THROUGHOUT THE PROVIDED TRACING. THERE ARE ALSO WARNINGS IN THE CORTRAK* 2 NG/NI FEEDING TUBE WITH ELECTROMAGNETIC TRANSMITTING STYLET IFU THAT WERE APPLICABLE FOR THE DESCRIBED INCIDENT, INCLUDING: "STOP INSERTION AND WITHDRAW THE TUBE WHEN THE CORTRAK* 2 MONITOR IS NOT DISPLAYING THE EXPECTED PATH (FIG. 6, 7 AND 8) AS OBSERVED BY A QUALIFIED CLINICIAN. DO NOT USE THE CORTRAK* 2 AS AN AID DURING A TUBE PLACEMENT IF NO SIGNAL OR AN UNEXPECTED OR UNUSUAL TRACING IS VISIBLE ON THE CORTRAK*2 MONITOR," "IF UNABLE TO ADVANCE THE TRANSMITTING STYLET INTO THE FEEDING TUBE DURING INSERTION OR IF RESISTANCE IS MET, STOP THE PROCEDURE AND DISCONTINUE USING THE CORTRAK* 2," AND "IF THE CORTRAK* 2 IMAGE IS NOT DISPLAYING THE EXPECTED PATH (FIG. 6, 7 AND 8) AS OBSERVED BY A QUALIFIED CLINICIAN OR IF THERE IS UNCERTAINTY OF THE TUBE'S DISTAL LOCATION AFTER FACILITY PLACEMENT VERIFICATION METHODS HAVE BEEN PERFORMED, ADDITIONAL CONFIRMATION METHODS SHOULD BE CONSIDERED". THE ROOT CAUSE WAS RELATED TO INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 11 SEP 2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    APPROPRIATE TERM / CODE NOT AVAILABLE HEALTH EFFECT - CLINICAL CODE: RESPIRATORY DISTRESS. THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2023, HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC. AVANOS MEDICAL INC. HAS NO INDEPENDENT KNOWLEDGE OF THE REPORTED EVENT BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CUSTOMER HAD AN ISSUE WITH A TUBE PLACEMENT WHERE IT WAS IN THE PATIENT¿S LUNG. X-RAY WAS COMPLETED, BUT WAS READ INCORRECTLY. THE PATIENT WAS FED FOR TWELVE HOURS VIA CORTRAK TUBE, WENT INTO RESPIRATORY DISTRESS, RECEIVED A CHEST TUBE, AND WAS INTUBATED IN THE MORNING. PER ADDITIONAL INFORMATION RECEIVED ON 12JUL2023, THE CORTRAK NASOGASTRIC TUBE (NGT) WAS PLACED ON (B)(6) 2023, AT 1445. AN X-RAY WAS OBTAINED ON (B)(6) 2023, AT 1504. LUNG PLACEMENT WAS DISCOVERED ON (B)(6) 2023, AT 0838. THE TUBE WAS PLACED IN THE LEFT LUNG. A CHEST TUBE WAS PLACED ON (B)(6) 2023, AT 0900 AND THE PATIENT WAS INTUBATED ON (B)(6) 2023, AT 1127. THE PATIENT WAS MOVED TO HOSPICE AND DIED ON (B)(6) 2023. THE PATIENT HAD NO UNUSUAL ANATOMY. THE FACILITY'S POLICY FOR CONFIRMATION OF TUBE PLACEMENT IS TO OBTAIN A KUB (KIDNEY, URETER, AND BLADDER X-RAY). PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, ¿HE [THE PATIENT] WAS TRANSITIONED TO HOSPICE THEREFORE THE FAMILY REMOVED ALL LIFE-SUSTAINING MEASURES (VENTILATOR WAS REMOVED).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258402 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other| L| D CHEST TUBE| CORTRAK NASOGASTRIC TUBE| CORTRAK RECEIVER UNIT 20-0952 SN (B)(6)