Posted 11 January 2018
By Zachary Brennan
The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers to provide information about reports of pneumothorax events, or collapsed lungs, and deaths associated with feeding tube placement procedures using some enteral access systems (EAS).
FDA has cleared three EAS devices for marketing in the US, the agency said, noting that each uses a different technology to track the position of the feeding tube during the insertion procedure and include: The Kangaroo Feeding Tube with IRIS Technology by Covidien, the Cortrak 2 Enteral Access System by Corpak Medsystems and the smARTrack Feeding Tube by ART Healthcare.
From January 2012 to July 2017, FDA said it received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Corpak Medsystems Cortrak 2 device, including 11 reports of patient deaths. FDA received one report of a non-fatal pneumothorax event associated with the Kangaroo Feeding Tube
with IRIS Technology.
"For both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases," the agency said. "The smARTrack device is not currently being sold within the United States and no MDRs have been received for this device."
The agency offered specific recommendations in its letter to health professionals, also noting: "Most reports indicate these 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 <0.5%, we are 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."
Feeding Tube Placement Systems - Letter to Health Care Providers
Editor's note: Article updated on 1/12/17 with new information from corrected FDA letter.