Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

From Drugs.com - January 11, 2018

Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events

Audience: Surgery, Critical Care Medicine

[Posted 01/11/2018]

ISSUE: The FDA is providing information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems (EAS). 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%, 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 Corpak Medsystems Cortrak 2 device. These included 11 reports of patient death. The FDA also received 28 MDRs about pneumothorax events related to the use of the Covidien Kangaroo device, including 5 deaths. For both devices, the relationship between the pulmonary events and the death cannot be concluded definitively in all cases. The smARTrack device is not currently being sold within the United States and no MDRs have been received for this device.

Because the MDR system is based on passive surveillance, FDA cannot determine how the rate of these complications compares to that estimated for blind insertion.

Continue reading at Drugs.com »