BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTRACK ENTERAL ACCESS SYSTEM

    MDR report key: 1780771 · Received July 27, 2010

    Report

    Report Number
    1419949-2010-00006
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 27, 2010
    Report Date
    July 26, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    PMA / PMN Number
    K091637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORTRAK UNIT AND/OR THE FEEDING TUBE HAVE NOT BEEN RETURNED FOR EVALUATION. HOWEVER, FEEDING TUBE PLACEMENT IS DEPENDENT ON THE CLINICIAN AND PATIENT. THE ACTUAL TUBE DOES NOT INFLUENCE WHERE IT IS PLACED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE, WAS ADMITTED FOR TRAUMA AFTER A CAR ACCIDENT FOR MULTIPLE LUNG CONTUSIONS, C5, C6, C7 AND T11 COMPRESSION FRACTURES. THE CLINICIAN ATTEMPTED INSERTING THE FEEDING TUBE SEVERAL TIMES. ACCORDING TO THE NURSE MANAGER, THE CORTRAK IMAGE INDICATED A RIGHT LUNG PLACEMENT BUT NO ACTION WAS TAKEN. THE PATIENT'S OXYGEN SATURATION THEN DROPPED BELOW 50%. AN X-RAY WAS TAKEN AFTER PLACEMENT TO CONFIRM TUBE PLACEMENT. A 50% RIGHT LUNG PNEUMOTHORAX RESULTED. THE PATIENT WAS INTUBATED AND A CHEST TUBE INSERTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention