January 31, 2018 — Feeding tube placement systems have been linked to deadly lung collapses, also known as “pneumothorax events,” according to a new Safety Alert from the FDA.
The FDA has received nearly 80 reports of lung collapses, resulting in 16 deaths, in patients who were treated with devices that help doctors place feeding tubes, according to the FDA.
The FDA outlined the problem in a “Letter to Health Care Providers” on January 11, warning that dozens of injuries and deaths are linked to the only two feeding tube placement devices on the market.
The devices are called Enteral Access Systems (EAS), and while they are supposed to prevent injuries associated with “blindly” placing a feeding tube, EAS devices pose their own serious safety risks.
Between January 2012 and July 2017, the FDA received 41 reports of injuries and 11 deaths associated with the Corpak Medsystems Cortrak 2® EAS. Another 28 injuries and 5 deaths were linked to the Covidien Kangaroo® EAS with IRIS Technology.
The Cortrak 2 uses electromagnetic sensors to create an image of the tip of the feeding tube to help a doctor guide it into the patient’s chest.
The Covidien Kangaroo uses a camera at the end of the tube to provide doctors with a live video of the intestines during placement.
The FDA recommends removing the feeding tube and re-assessing the patient if it encounters resistance during placement, or if the patient develops respiratory distress, coughing, or shortness of breath.
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