Notes

Avanos Medical faces Class I recall because of feeding tube connection that led up to 23 deaths.

The FDA has issued its most severe warning in relation to the recall of Avanos Medical's feed tube enteral positioning system.

https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ The Cortrak*2 Enteral Access System includes an electromagnetic stylet as well as an external receiver, and a display monitor. The system is able to be combined to show a live stream that shows the process of inserting a feeding tube into the stomach of a patient. This procedure is carried out in the hope of increasing precision and reducing the risk of complications.

Avanos announced the recall earlier in the month of every Cortrak*2 device that was in use between January 20,21 between January 20,22 and January 20,21. It involved nearly 630 devices.

RELATED
A tiny widget claims to provide greater security and causes chaos inside tube feeders
The safety event isn't a recall in its literal sense: Avanos does not ask health professionals to return the devices back to the manufacturers. Instead, it wants to ensure that users are using the devices correctly.

If a tube for feeding is placed incorrectly, it can damage the vocal cords, lungs, or trachea and cause severe injury or death. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos was informed of 23 deaths and 60 injuries in the year 2015 by the FDA. These incidents were all connected to the Cortrak*2 system that controls the placement of feed tubes.

Some of the injuries reported include respiratory failure, collapsed lung infected lung, as well as holes within the walls of the esophagus and the lungs.

The FDA reminded users that they must confirm that they have placed a nasogastric tube according to their institutional policies in the March 21 field correction notification. Avanos advised users to add the safety announcement to the system's operation manual and then confirm that they have notified Avanos that the update was received.

Avanos announced that it will shortly issue updated labeling for the device, which will include the direction to map out the tube's location in accordance the policies of their facility prior to using the system to help set up the tube.

RELATED
FDA requests Philips to repair, replacement or reimbursement on all ventilators that were removed from the market.
This marks the second warning the FDA has issued in the past year in regards to the use of enteral feeding tubes. Cortrak 2 eternal access system In February, the FDA issued an safety alert for parents and healthcare providers regarding the danger of strangulation for children who use feeding tubes.

This announcement was made in response to two deaths reported in 2021. The notice followed two reports of deaths in 2021. Cortrak 2 eternal access system In both instances the tubing system was found to have been wrapped around the necks of patients who were under the age of 2.

Cortrak 2 eternal access system "While the FDA believes that death or serious injury caused by strangulation from enteral feeding tubing in children is rare healthcare professionals and caregivers should be aware that such events can and do occur," the agency said in its notice, suggesting that other similar incidents may not have been reported to the FDA.


Read More: https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A