Cases of collapsed lung, called a pneumothorax event, have been reported in patients who were given feeding tubes using enteral access systems (EAS), a particular type of system to guide clinicians in the placement of enteral feeding tubes, the Food and Drug Administration (FDA) cautioned in a Safety Communication.
“Most reports indicate these pulmonary events required urgent intervention, including needle decompression or chest tube placement,” the notification stated. “Several of these effects were associated with cardiopulmonary arrest and patient death.” Pneumothorax is a known rare complication of “blind insertion” of feeding tubes. But use of EAS devices does not eliminate this risk, the agency reminded health care professionals.
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 U.S., each of which uses a different technology to track the position of the feeding tube during the insertion procedure – the Cortrak2 Enteral Access System by Corpak Medsystems, the Kangaroo Feeding Tube with IRIS Technology by Covidien, and the smARTrack Feeding Tube by ART Healthcare.
From January 2012 to July 2017, the FDA has received 51 Medical Device Reports (MDRs) about pneumothorax events related to use of the Corpak Medsystems Cortrak 2 device, including 11 reports of patient death. The FDA has also received 28 MDRs about pneumothorax events related to use of the Covidien Kangaroo device, including five deaths. For both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases. The smARTtrack device is not currently being sold within the U.S. and no MDRs have been received for this device.
The agency said that since the MDR system is based on passive surveillance, it cannot determine how the rate of these complications compares to that estimated for blind insertion.
The FDA is offering recommendations to health care professionals to follow prior to and during use of EAS for feeding tube insertion. Any adverse events related to this issue should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
“Prompt reporting of adverse events helps the FDA identify and better understand the risks associated with medical devices,” the Safety Alert stated.
Source: FDA Safety Alert