Notes

Avanos Medical faces a Class I recall for its feeding tube system connected to 23 deaths that occurred in 2015

The FDA has issued the most severe of warnings in relation to the recall of Avanos Medical’s enteral feeding tube positioning system.

Cortrak*2 Enteral Access System contains an electronic stylet and an external receiver. When they are used together the system provides a live feed of the positioning of medical-grade feeding tubes into the stomach of a patient or into their small bowel, with an intention of improving the accuracy of the tube's tip placement and reducing the risk of complications.

In spite of that goal however, the system has been implicated in the occurrence of many injuries sustained by patients, leading Avanos to launch a recall earlier this year of all Cortrak*2 devices between January 2021 and January 2022, totalling more than 630 devices that were distributed between April 2016 and the start of this year.

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The safety event is not a reason to issue an recall. Avanos has asked healthcare providers to not send the devices back to the manufacturer. However, they want to make sure that they are using the devices.

A wrongly placed feeding tube can damage vocal cords and the lungs. It may also cause serious injury or even death. Avanos has reported 23 deaths and 60 injury cases in 2015 as per the FDA. Avanos Medical This is all because of the FDA's Cortrak*2 system which directs the placing feeding tubes.

Avanos Medical There are many injuries which have been reported including respiratory failure, collapsed lung, lung infection.

According to FDA Georgia-based Avanos issued a March 21 field correction notice reminding patients to confirm the position of nasogastric tubes as well as tubs for the nasoenteric system according to institution guidelines. Avanos advised users to include the safety notice in the system's operation manual and confirm with Avanos that the change was accepted.

https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Avanos Mediacal Cortrak 2 Avanos announced that they will soon issue new labeling on the device. The label will contain the directions to put a tube according to their policies.

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This is the FDA's second warning this year about enteral feeding tubes. The FDA released a safety communication in February warning parents and healthcare professionals of the danger of strangulation if children are feeding through tubes.

Avanos Medical Two deaths in 2021 were reported to the notice. In both instances, a tubing system was discovered be wrapped around the neck of a patient younger than 2 while they weren't being directly observed by their staff members or caregivers.

"The FDA believes that strangulation with tubing for feeding through the enteral system in children is uncommon, but healthcare professionals and caregivers have be aware that these instances can occur and can occur," the agency stated in the notice. This indicates that similar incidents might not have been reported to FDA.

Avanos Mediacal Cortrak 2
Website: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm