BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 8571343 · Received May 1, 2019

    Report

    Report Number
    3006646024-2019-00008
    Event Type
    Death
    Date Received
    May 1, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 19, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECT SERIAL NUMBER FOR THE REPORTED DEVICE WAS RECEIVED ON (B)(6) 2019. SEE SECTION D4 FOR THE SERIAL NUMBER. THE DEVICE HISTORY RECORD FOR SERIAL NUMBER (B)(4) WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE INVESTIGATION IS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2019 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH 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

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. AFTER THE SETUP OF THE CORTRAK SYSTEM AND THE COMPLETION OF THE INITIALIZATION, THE FUNCTIONALITY OF THE RETURNED UNIT PERFORMED AS INTENDED. MULTIPLE TRACINGS PULLED FROM THE CORTRAK SYSTEM DATED ON THE DATE OF THE REPORTED EVENT WERE NOTED TO HAVE THE POTENTIAL RIGHT LUNG PLACEMENT. ALL INFORMATION REASONABLY KNOWN AS OF 19 JUN 2019 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH 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

    THIS REPORT IS SUBMITTED TO PROVIDE CLARIFICATION TO SECTION B5. THE INVESTIGATION REMAINS IN PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 13 JUN 2019 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH 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.

    Description of Event or Problem · 0

    CLARIFICATION OF THE EVENT DESCRIPTION IS AS FOLLOWS: AN UNKNOWN FEEDING TUBE WAS USED WITH THE CORTRAK EAS (ENTERAL ACCESS SYSTEM). THE UNKNOWN FEEDING TUBE WAS INSERTED INTO THE PATIENT'S LUNG. THE CORTRAK EAS CONFIRMS BEDSIDE TUBE PLACEMENTS WITHOUT X-RAY.

    Additional Manufacturer Narrative · 1

    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 01 MAY 2019 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 EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED "WE HAVE HAD ANOTHER PATIENT EVENT RELATED TO CORTRAK INSERTION. PATIENT DEVELOPED A PNEUMOTHORAX AFTER CORTRAK WAS INSERTED INTO THE LUNG. ADDITIONAL INFORMATION RECEIVED 23-APR-2019 INDICATED THE PATIENT STATUS IS DECEASED. RIGHT LUNG INVOLVEMENT. MEDICAL INTERVENTION INCLUDED CHEST TUBE PLACEMENT AND INTUBATION. IN REGARDS TO THE CAUSE OF DEATH, THE COMPLAINANT STATED ON (B)(6) 2019, "I CANNOT SPECULATE IN THE CAUSE OF DEATH BUT IT APPEARS THERE WERE MANY CIRCUMSTANCES THAT CONTRIBUTED TO DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361932 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death