BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 13345075 · Received January 25, 2022

    Report

    Report Number
    3011270181-2022-00002
    Event Type
    Death
    Date Received
    January 25, 2022
    Date of Event
    January 2, 2022
    Report Date
    April 30, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770472010
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT [1512012] WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 24 JAN 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, (B)(6) 2022, (B)(6) 2022; D4; H6. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED AND THE EVALUATION WAS COMPLETED AND THE DEVICE WAS FOUND TO BE FUNCTIONING AS INTENDED. THE DEVICE HISTORY RECORD FOR LOT 1512012 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 22 FEB 2022 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 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

    ALL INFORMATION REASONABLY KNOWN AS OF 30 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED IN THE PATIENT¿S LEFT LUNG, USING THE CORTRACK MACHINE; A PNEUMOTHORAX WAS NOTED ON X-RAY AND THE DOBHOFF NASO-DUODENAL FEEDING TUBE (DHT) WAS REMOVED. THE PATIENT WAS REPORTED TO BE ALERT AND OPTED FOR NO FURTHER TREATMENT AND REQUESTED TO BE TRANSITIONED TO COMFORT CARE; THE PATIENT WAS REPORTED TO HAVE PASSED AWAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATED THAT WHEN THE TUBE WAS PLACED APPROXIMATELY 200CC OF AIR WAS INJECTED INTO THE TUBE WITH PLACEMENT AND THE PATIENT DID NOT DESATURATE, COUGH OR COMPLAIN OF PAIN. A CHEST XRAY (CXR) WAS PERFORMED AND NOTED: COMPLETE OPACIFICATION OF THE LEFT HEMITHORAX, (NEW FROM THE PRIOR STUDIES) WITH APPARENT VOLUME LOSS WHICH MAY BE SECONDARY TO MUCOUS PLUGGING/BRONCHIAL OBSTRUCTION AND COMPLETE LEFT LUNG ATELECTASIS. ADDITIONALLY IT WAS NOTED THAT THE DISTAL TIP OF THE FEEDING TUBE PROJECTED OVER THE LEFT LUNG BASE AND WAS DIFFICULT TO DISCERN AS TO WHETHER THE CATHETER WAS ESOPHAGEAL OR WITHIN THE TRACHEA/BRONCHI; THE FEEDING TUBE WAS REMOVED OUT OF CAUTION. A CHEST CAT SCAN (CT) WAS PERFORMED AND NOTED . COMPLETE LEFT LUNG ATELECTASIS WITH EXTENSIVE MUCOUS PLUGGING, SUPERIMPOSED ASPIRATION; PNEUMONIA IN THE ATELECTATIC REGIONS NOT EXCLUDED; SMALL MODERATE SIMPLE REACTIVE LEFT PLEURAL EFFUSION; MODERATE CENTRILOBULAR EMPHYSEMA; PATCHY RIGHT LOWER LOBE CONSOLIDATION CONSISTENT WITH ASPIRATION; PNEUMONIA OR ATELECTASIS; MILD MUCOUS PLUGGING NOTED IN THE POSTERIOR BASAL RIGHT LOWER LOBE. TUBE FEEDING (TF) WAS STARTED AND THE PATIENT RECEIVED 500CC OF TUBE FEEDS & FLUSH, THERE WAS NO MENTION OR EVIDENCE OF TF BEING PRESENT ON CT OR CXR. THE PATIENT REFUSED ANY FURTHER MEDICAL INTERVENTION AND WAS TRANSFERRED TO COMFORT CARE; THE TUBE WAS NOT REPLACED NOR WAS THE CHEST TUBE INSERTED. ADDITIONAL INFORMATION STATED THE PATIENT¿S CAUSE OF DEATH (COD) AS: ACUTE RESPIRATORY FAILURE - SECONDARY TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION, ASPIRATION PNEUMONIA (PNA). ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS NOT INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703297 CORTRAK ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 1512012 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death| L| O