BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 11532048 · Received March 19, 2021

    Report

    Report Number
    3011270181-2021-00016
    Event Type
    Death
    Date Received
    March 19, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 12, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORTRAK SYSTEM WAS EVALUATED, A PLACEMENT TEST WAS CONDUCTED AND BOTH THE MONITOR UNIT AND RECEIVER UNIT PASSED THE PLACEMENT TEST. ADDITIONALLY, THE TRACINGS WERE RETRIEVED FROM THE DEVICE AND REVIEWED. IT WAS DETERMINED THAT TRACING 20210128143544 CROSSED INTO THE LEFT LUNG AREA 9 SECONDS INTO THE TRACING AND REMAINED IN THAT AREA UNTIL 1 MINUTE AND 45 SECONDS INTO TRACING, AT WHICH POINT THE TRACING INDICATES THE NG TUBE WAS PULLED OUT. ACCORDING TO COMPLAINT DESCRIPTION, "OPERATORS WERE TWO NURSE AND EXPERIENCED CORTRAK USERS THAT ATTENDED PREVIOUS TRAINING." THEREFORE, IT WAS DETERMINED THAT THE USER WAS TRAINED ON THE CORTRAK SYSTEM AND THE INCIDENT RESULTED FROM THE USER BEING UNABLE TO INTERPRET THE CORTRAK SYSTEM'S TRACING. THE ROOT CAUSE WAS INCORRECT USE. ALL INFORMATION REASONABLY KNOWN AS OF 20-MAY-2021 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 AVANOS MEDICAL, INC. 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

    SOFTWARE RELEASE 2.4.8. ALL INFORMATION REASONABLY KNOWN AS OF 12 APR 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 · 1

    APPROPRIATE CLINICAL SIGNS, SYMPTOMS, CONDITIONS TERM / CODE NOT AVAILABLE: DEATH. THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR THE REPORTED SERIAL NUMBER, (B)(4), IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 19-MAR-2021 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA FDA MEDWATCH/INQUIRY USER FACILITY REPORT # (B)(4) THE FOLLOWING: "CORTRAK PLACED. PATIENT DECOMPENSATED FOLLOWING INSERTION (RESPIRATORY DISTRESS AND EVENTUAL CARDIAC ARREST); CODE BLUE CALLED. PATIENT EXPIRED." ADDITIONAL INFORMATION RECEIVED 24-FEB-2021 STATING THE PATIENT WAS INTUBATED. FURTHERMORE, THE PATIENT EXPIRED AT 1518 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427236 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death RECEIVER UNIT #(B)(6).