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FDA Reports Fatal Pneumothorax Events Linked to Two Enteral Feeding Tubes (Updated)

Update, January 17: The US Food and Drug Administration (FDA) has issued an update to the information provided below. The previous letter issued on January 11, 2018 attributed an inaccurate number of adverse events and deaths to the Kangaroo Feeding Tube with IRIS Technology. Please see the highlighted text for updated information.

Washington, DC: The FDA has received reports of life-threatening and fatal pneumothorax events associated with feeding tube placement procedures using two FDA-approved enteral access systems (EAS).

EAS are designed to aid in the placement of naso-enteric feeding tubes by transmitting real-time positional information to an external visible screen or console. The FDA has cleared three EAS devices for marketing in the United States, each of which uses a different technology to track the position of the feeding tube during the insertion procedure.

The FDA states in its notice to health care professionals that most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of these events were associated with cardiopulmonary arrest and patient death. Although pneumothorax is a known rare complication of “blind insertion” of feeding tubes, typically less than 0.5 percent, the FDA is alerting clinicians that the use of EAS devices does not eliminate this risk and reminding health care providers of important safety information about these systems.

From January, 2012, to July, 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Cortrak device. These included 11 reports of patient death. The relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. In addition, because the MDR system is based on passive surveillance, the agency cannot determine how the rate of these complications compares to that estimated for blind insertion.

During that same period of time, the FDA received one report of a non-fatal pneumothorax event associated with the Kangaroo Feeding Tube with IRIS Technology. That event occurred following blind placement of the tube, without use of the video console.

The Kangaroo Feeding Tube with IRIS Technology by Covidien employs a camera embedded in the distal end of the tube and provides a video stream of the gastrointestinal tract during placement.

The Cortrak 2 Enteral Access System by Corpak Medsystems uses electromagnetic sensors in a stylet to provide a visual representation of the tip of the tube relative to an external receiving unit placed over the patient’s xiphoid process.

The FDA cautions that for both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases.

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