Important Safety Alerts

The United States Food and Drug Administration (FDA) issued a letter to the health care providers about reports of pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems. 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%, the FDA is alerting clinicians that the use of this device does not eliminate this risk and reminding health care providers of important use information for EAS systems.

From January 2012 to July 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the use of the Cortrak device. These included 11 reports of patient death. The relationship between the pulmonary events and the death however, cannot be concluded definitively in all cases. In addition, because the MDR system is based on passive surveillance, the FDA cannot determine how the rate of these complications compares to that estimated for blind insertion.

During that same period of time, FDA received one report of a non-fatal pneumothorax event associated with the Kangaroo Feeding Tube with IRIS Technology. That event occurred following blind placement of the tube, without use of the video console. The smARTrack device is not currently being sold within the United States and no MDRs have been received for this device. No MDRs have been received for the smARTrack device this device.

For Enteral Access Systems, the FDA recommends:

• The device only is 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 or the patient demonstrates any signs of respiratory distress, including cough or shortness of breath, the tube should be withdrawn and the patient re-assessed.
• Confirmation of the final tube position should be done per institution protocol, in particular if any difficulty occurred during insertion.

For details, please refer to the FDA websites:
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm591838.htm
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592051.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 15 January 2018