Certain systems designed to help guide feeding tubes into position have been linked to reports of lung collapses and patient deaths, according to federal health officials.
The FDA issued a warning to health care providers on January 11, indicating that nearly 80 reports of lung collapses, known as pneumothorax events, have been linked to the Cortrak 2 and Covidien Kangaroo Feeding Tube enteral access systems (EAS) between January 2012 to July 2017. The problems resulted in at least 16 reports of patient deaths.
The devices are the only such EAS’s currently sold in the United States, and are designed to help medical professionals put naso-enteric feeding tubes in place. They are meant to prevent injuries sometimes caused by “blind insertion” of feeding tubes by transmitting real-time positioning data to a screen or console.
While they are meant to help prevent pneumothorax events, which can lead to cardiopulmonary arrest and death, the FDA is warning that they do not eliminate those risks entirely.
Three EAS devices are approved for sale in the United States; Covidien’s Kangaroo Feeding Tube with IRIS Technology, the Corpak Medsystems Cortrak 2 Enteral Access System, and ART Healthcare’s smARTrack Feeding Tube. However, the smARTrack is not currently being sold in the United States.
The FDA received at least 51 Medical Device Reports of Pneumothorax events linked to the use of the Cortrak 2 form 2012 to 2017, including 11 patient deaths. During the same time period, it received 28 reports involving the Kangaroo, including five patient deaths.
The agency notes that it cannot definitively conclude that there was a link between the lung collapses and the feeding tube systems in every case.
Health care providers using the feeding tube systems are being urged to ensure that only staff who have received the prerequisite training provided by the manufacturer, and who are credentialed to place feeding tubes handle the operation of the devices. In addition the agency recommends that the devices not be used on patients who are contraindicated for naso-enteric feeding tubes. The FDA also advises that the tube be withdrawn and the patient reassessed in any cases where the tube meets resistance during placement, or the patient shows signs of respiratory distress, including cough or shortness of breath.
However, the agency provided additional recommendations specific to the Cortrak 2, which was linked to the highest number of incidents and patient deaths. The FDA recommends that the user verifies that the receiver of the feeding tube is aligned properly throughout the procedure and does not move, that the user observe and assess the real-time tracing to ensure the proper path of the tube, and that the device be used with caution in proximity to other electrical equipment.
The FDA warns that in some cases, equipent emitting in the 20-300 kHz frequency band may impact the Cortrak 2’s readings.
Adverse events, injuries and malfunctions related to these feeding tube systems should be reported to MedWatch, the FDA’s adverse event reporting system.