BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    MDR report key: 11517424 · Received March 18, 2021

    Report

    Report Number
    3011270181-2021-00013
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    February 20, 2021
    Report Date
    May 20, 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
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONITOR UNIT, RECEIVER UNIT, AND STYLET WERE NOT RETURNED, HOWEVER, TRACINGS OF SAMPLE WERE PROVIDED AND WERE REVIEWED. AFTER REVIEWING SEVERAL OF THE ATTACHED CORVIEW VIDEO TRACINGS, IT WAS NOTED TRACING 20210220114014 SHOWED DEVIATION INTO THE RIGHT LUNG AREA AT 44 SECONDS AND CONTINUED IN AN ABNORMAL FASHION CONTINUING OFF TRADITIONAL GI PATH FOR THE REMAINDER OF TRACING (ABOUT 11 MINUTES). 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 DETERMINED TO BE USER ERROR. ALL INFORMATION REASONABLY KNOWN AS OF 07-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

    ALL INFORMATION REASONABLY KNOWN AS OF 20-MAY-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 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 · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1512012, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 17-MAR-2021 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS "ADMITTED AS A CARDIAC ARREST. HAD RIB [FRACTURE] AND DEVELOPED PNA (PNEUMONIA)." THE PATIENT WAS EXTUBATED ON (B)(6) 2021. A FEEDING TUBE PLACEMENT WAS ATTEMPTED (B)(6) 2021 BY A CORTRAK USER AFTER A FAILED SWALLOW EVALUATION BY THE SPEECH THERAPIST. AN X-RAY NOTED THE NASOGASTRIC TUBE (NGT) WAS IN RIGHT LUNG. THE NGT WAS REMOVED. A FEEDING TUBE WAS PLACED BY THE PHYSICIAN. THE NGT WAS CONFIRMED IN THE GASTROINTESTINAL TRACT BY A KIDNEYS, URETHRA AND BLADDER (KUB) X-RAY AND A PNEUMOTHORAX WAS NOTED. A CHEST TUBE WAS PLACED FOR TREATMENT OF THE RIGHT LUNG PNEUMOTHORAX, ADDITIONAL INFORMATION RECEIVED 22-FEB-2021 STATED THE PATIENT IS RECOVERING FROM A RIGHT LUNG PNEUMOTHORAX WITH A CHEST TUBE PLACED FOR TREATMENT. THE PATIENT HAS NOT EXPERIENCED INCREASED OXYGEN THERAPY NEEDS. THE PHYSICIAN REPLACED THE NGT VIA FLUOROSCOPY "BLIND PLACEMENT, VERIFIED BY KUB." UPON VIEWING THE TRACINGS THE CUSTOMER RECOGNIZES IT WAS AN OPERATOR ERROR, THE CORTRAK IS IN GOOD WORKING ORDER AND WAS NOT AT FAULT THEY DO NOT FEEL IT IS NECESSARY TO RETURN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410427 CORTRAK 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 00350770472010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention NG-TUBE: 20-9551TRAK2| RECEIVER UNIT: 1603014