FDA Issues Letter to Health Care Providers About Pneumothorax Events

JANUARY 11, 2018
Matt Hoffman
The US Food and Drug Administration (FDA) has released information about pneumothorax events involved with feeding tube placement procedures done with enteral access systems (EAS).

In total, from January 2012 to July 2017, the FDA reportedly received 79 Medical Device Reports (MDRs) pertaining to pneumothorax events related to the Corpak Medsystems Cortrak 2 device (51 reports, including 11 deaths) and the Covidien Kangaroo device (28 reports, including 5 deaths). A relationship between pulmonary events and death in the 16 total cases could not be definitively concluded.

Although pneumothorax occurs <0.5% of the time, the FDA advises that utilizing EAS devices does not eliminate the risk of this complication of blind insertion.

The FDA advised that when using EAS devices.:
  • The device only be used by clinical staff who have received the prerequisite training developed by the manufacturer and who are credentialed within their institution to place an enteral feeding tube.
  • The device not be used in patients who have contraindications for naso-enteric feeding tubes in general.
  • If any resistance is met during placement of the patient demonstrates any resigns of respiratory distress, including a cough or shortness of breath, the tube should be withdrawn and the patients reassessed.
  • Confirmation of the final tube position should be done per institution protocol, in particular, if:
    • Any difficulty occurred during insertion;
    • The patient displayed any signs of respiratory distress during or after the procedure;
    • The tube’s path during placement appeared to deviate from the expected or final location is uncertain;
    • The patient has a variation in normal gastrointestinal anatomy; or
    • The patient is intubated or has an altered level of consciousness.

Specifically, for the Corpak Medsystems Cortrak 2 device, the FDA advised that the user exercise caution when using the device in close proximity with other electrical equipment (specifically those emitting in the 20-300 kHz frequency band), and both ensure the receiver is aligned properly and that it does not move. Additionally, the FDA recommended the user observe and assess real-time tracing data to “ensure the proper path of the tube.”

The FDA advises reporting adverse events promptly. To submit a report online, go to www.fda.gov/MedWatch/report. Otherwise, the form can be downloaded, requested by phone at 1-800-332-1088, and returned to the pre-addressed location.

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