On January 11, the FDA published a “Letter to Health Care Providers” to warn that nearly 80 cases of lung collapses — known as pneumothorax events — have been linked to two devices that are used to help doctors place feeding tubes, resulting in 16 deaths.
Only two types of these devices are currently sold in the U.S., and they are also called “Enteral Access Systems” or EAS.
They are supposed to prevent injuries that are caused by blindly inserting feeding tubes by transmitting real-time positioning data to a screen or console that is viewed by a doctor.
Unfortunately, EAS devices pose their own life-threatening risks. From January 2012 to July 2017, the FDA received 51 reports of pneumothorax events from the use of the Corpak Medsystems Cortrak 2® EAS feeding tube system — including 11 reports of patient death.
The FDA also received 28 reports of pneumothorax events from the Covidien Kangaroo® EAS feeding tube device, including 5 deaths.
The Covidien Kangaroo Feeding Tube with IRIS Technology uses a camera in the far end of the tube to give doctors a live video stream of the patient’s intestinal tract during placement of the feeding tube.
The Cortrak 2 Enteral Access System uses electromagnetic sensors in to provide doctors with an image of the tip of the tube relative to an external receiving unit that is placed over the patient’s chest.
The FDA recommends that the feeding tube should be removed if it meets resistance during placement, or if the patient shows signs of respiratory distress, including cough or shortness of breath.