BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRAK ENTERAL ACCESS SYSTEM

    MDR report key: 1399587 · Received June 3, 2009

    Report

    Report Number
    1419949-2009-00003
    Event Type
    Injury
    Date Received
    June 3, 2009
    Date of Event
    April 9, 2009
    Report Date
    May 29, 2009
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    PMA / PMN Number
    K080679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US

    Narratives

    Additional Manufacturer Narrative · 1

    FEEDING TUBE PLACEMENT IS DEPENDENT ON THE CLINICIAN AND PATIENT. THE ACTUAL TUBE DOES NOT INFLUENCE WHERE IT IS PLACED. THE FEEDING TUBE PLACEMENT RECORDS WERE REVIEWED FOR THE PATIENT INVOLVED. THE PLACEMENTS VIEWED DO NOT SHOW A TYPICAL GI PLACEMENT. THE PLACEMENTS REVIEWED INDICATED LUNG PLACEMENT BASED ON THE PATH SEEN WHEN REVIEWING THE CORTRAK UNIT. IN ADDITION, PLACEMENTS WERE VIEWED BOTH BEFORE AND AFTER THE INDICATED LUNG PLACEMENT AND FOUND TO REPRESENT TYPICAL GI PLACEMENTS. THE CORTRAK UNIT CONTINUED TO BE USED BY THE FACILITY ROUTINELY BETWEEN THE DATE OF THE INCIDENT (2009) AND ITS RETURN IN THE FOLLOWING MONTH.

    Description of Event or Problem · 1

    THE CORTRAK WAS GETTING SOME ARTIFACT ON THE SCREEN, SHOWING THE FEEDING TUBE IN THE MIDDLE OF THE SCREEN WHEN IT HAD NOT PASSED THE BACK OF THE THROAT. ADDITIONAL INFORMATION RECEIVED 05/12/2009: RN INSERTING INTO ESOPHAGUS - THE IMAGE IS NOT QUITE MIDLINE TO RIGHT SIDE OF SCREEN - DEPTH OK. X-RAY CONFIRMED THE FEEDING TUBE WAS IN THE RIGHT LUNG. PATIENT DEVELOPED A SMALL PNEUMOTHORAX AND WAS ADMINISTERED 100% OXYGEN AND IT RESOLVED. SINCE PATIENT WAS ALREADY INTUBATED, THE GAG AN COUGH REFLEX'S WERE DIMINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTRAK ENTERAL ACCESS SYSTEM CORTRAK FPD CORPAK MEDSYSTEMS 20-0900 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R