BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORTRAK* 2 ENTERAL ACCESS SYSTEM

    MDR report key: 7924738 · Received October 1, 2018

    Report

    Report Number
    3006646024-2018-00034
    Event Type
    Death
    Date Received
    October 1, 2018
    Report Date
    November 13, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10815149024582
    PMA / PMN Number
    K113351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 25-OCT-2018 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).

    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-OCT-2018 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 1605001, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ONE (1) CORTRAK EAS UNIT WAS RETURNED. THE MONITOR UNIT WAS INSPECTED FOR DAMAGES AND BREAKAGES, THERE WERE NO BREAKAGES OR DAMAGES FOUND ON THE BLUE HOUSING AND ORANGE BUTTON. THE DEVICE WAS EVALUATED BY CONNECTING THE RETURNED MONITOR UNIT, SMART RECEIVER UNIT (SRU) INTERCONNECT CABLE TO THE LAB'S ANATOMICAL MODEL AND TRANSMITTING STYLET. FUNCTIONAL TESTING OF THE UNIT INDICATED THAT THE UNIT WORKS AS INTENDED. AFTER THE SETUP, VERIFICATION OF THE CORTRAK SYSTEM AND THE COMPLETION OF THE INITIALIZATION, THE FUNCTIONALITY OF THE UNIT PERFORMED AS INTENDED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PLACEMENT TRACINGS WERE NOT PRESENT. THE ROOT CAUSE WAS NOT IDENTIFIED. ALL INFORMATION REASONABLY KNOWN AS OF 11-DEC-2018 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

    A MEDWATCH (MW) REPORT, FDA REPORT NUMBER FDA 3500 FORM (B)(4), WAS RECEIVED. IT WAS REPORTED THAT A FEEDING TUBE WAS PLACED USING THE CORTRAK 2 SYSTEM. WAVE FORM THE SAME AS WAVE PLACEMENT FROM 2 DAYS EARLIER. KIDNEY, URETER, AND BLADDER (KUB) X-RAY OBTAINED DUE TO CORTRAK BEING ONLY AT 45 MARK TO MAKE SURE IT WAS IN THE STOMACH. A DOCTOR TOLD BEDSIDE NURSE IT WAS OK TO USE. WHEN BEDSIDE NURSE WENT TO USE TUBE, THERE WAS A LARGE AMOUNT OF BLOOD COMING FROM THE TUBE. HAD SECRETARY CALL RADIOLOGY TO GET A STAT READING ON THE X-RAY. THE TUBE WAS REMOVED IN THE MEANTIME RADIOLOGY MD STATED THE TUBE WAS IN THE RIGHT LUNG. THE PT BEGAN TO DECLINE WITH DECREASING BLOOD OXYGEN SATURATION (SPO2) AND EVENTUALLY TO THE POINT A CODE BLUE WAS CALLED, DURING THE VERY LENGTHY CODE, THE HUSBAND WAS CALLED AND HE SAID TO STOP THE CODE THE CODE BLUE WAS STOPPED AND PT EXPIRED. ANOTHER DOCTOR WAS PRESENT FOR THE CODE. WHEN ASKED HE SAID NOT TO CALL THE MEDICAL EXAMINER AS IT WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764298 CORTRAK* 2 ENTERAL ACCESS SYSTEM DH CORTRAK (EAS) KNT AVANOS MEDICAL INC. 20-0950 1605001 10815149024582

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death