BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KEOFEED TUBE

    MDR report key: 4231615 · Received October 31, 2014

    Report

    Report Number
    MW5038951
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    February 25, 2014
    Report Date
    October 31, 2014
    Manufacturer
    CORPAK
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, AT THE (B)(6), RN 3 HAD AN ORDER TO INSERT A KEOFEED INTO PATIENT 3. THE CORTRAK MACHINE WAS SET UP AND KEOFEED WAS INSERTED USING PATIENTS IDENTIFICATION NUMBER. IT WAS DIFFICULT TO INSERT BECAUSE THE PATIENT HAD A NASOGASTRIC TUBE IN PLACE FOR SUCTIONING. SO, BOTH NOSTRILS WERE ATTEMPTED. THE INSERTION DID NOT SHOW UP ENTERING THE LEFT LOWER QUADRANT AND CROSSING TO THE RIGHT. IT STAYED MIDLINE AND SLIGHTLY RIGHT, THEN ENTERED INTO THE RIGHT LEFT QUADRANT. WHEN THE NURSE ASPIRATED, THERE WAS A SEROUS RETURN. AFTER THE PROCEDURE, THE OXYGEN SATURATION CHANGED TO 80-83%. AFTER THE X-RAY SHOWED THE KEOFEED WAS INSERTED INTO THE RIGHT LUNG. THE TUBE WAS PULLED OUT. CHEST TUBE WAS INSERTED. PATIENT WAS PLACED BACK ON MECHANICAL VENTILATION. X-RAY REPORT SHOWED LARGE RIGHT PNEUMOTHORAX, DUE TO KEOFEED COURSES INFERIORLY OVER THE RIGHT HEMITHORAX, TIP PROJECTING OVER THE RIGHT LOWER, LOWER/RIGHT UPPER QUADRANT. MANUFACTURER WAS NOT NOTIFIED OF POSSIBLE DEFECTIVE PRODUCT, BECAUSE THE NURSE THREW THE PRODUCT AWAY. PATIENT DIED ON (B)(6) 2014 OF CARDIOPULMONARY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698083 KEOFEED TUBE KEOFEED TUBE KNT CORPAK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening