BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 9849317 · Received March 18, 2020

    Report

    Report Number
    3011270181-2020-00048
    Event Type
    Death
    Date Received
    March 18, 2020
    Date of Event
    February 6, 2020
    Report Date
    April 12, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651472011
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1708005, 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 24-JUN-2020 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. H6: INVESTIGATION FINDINGS: 4247- APPROPRIATE TERM/CODE NOT AVAILABLE: USAGE PROBLEM IDENTIFIED THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE EVALUATION DETERMINED THAT THE UNIT WAS FUNCTIONING AS INTENDED. THE TRACING PROVIDED DID NOT FOLLOW TYPICAL PLACEMENT PATTERN, AND CUSTOMER CONFIRMED OPERATOR WAS NOT TRAINED AND LUNG DEVIATION COULD BE SEEN ON MONITOR UNIT SCREEN. THE ROOT CAUSE WAS DETERMINED TO BE USER-INCORRECT USE. 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

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18-MAR-2020 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. 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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED A CLINICIAN NOT ON THE CORTRAK TEAM ATTEMPTED TO INSERT A NASO-INTESTINAL (NI) TUBE WITH THE CORTRAK DEVICE. THE TRACING SHOWED THE "TUBE OBVIOUSLY WAS GOING TOWARD THE RIGHT LUNG." A PNEUMOTHORAX OCCURRED. ADDITIONAL INFORMATION RECEIVED 25-FEB-2020 STATED THE "NURSE ON THE CORE CORTRAK TEAM WAS ASSISTING. X-RAY CONFIRMED PNEUMOTHORAX OCCURRED." THE USER FACILITY DID NOT REALIZE THERE WAS AN ISSUE UNTIL THE PATIENT BECAME AGITATED A FEW HOURS LATER. AGAIN, AN X-RAY WAS TAKEN AND CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED IN THE PATIENT. THE PATIENT WAS INTUBATED DUE TO RESPIRATORY FAILURE RELATED TO HIS DISEASE. THE PATIENT HAD END STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND DIED, ON (B)(6) 2020 AT 13:50, FROM ISSUES UNRELATED TO THE PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310684 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 N/A 10680651472011

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| D CHEST TUBE PLACED.| CHEST TUBE PLACED