Notes

Avanos Medical faces Class I recall for the feeding tube system implicated in 23 deaths in 2015

Seven years after adversity for the Avanos Medical enteral feeding tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has given its most severe designation for recalls of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver and an LCD monitor. feeding tube placement The system is able to be used in conjunction to provide a live feed which shows the process of inserting a medical feed tube in the stomach of a patient. This procedure is carried out with the aim of improving the accuracy of the procedure and decreasing complications.

Avanos was not happy with its mission and launched an recall of all Cortrak*2 units between January 2021 & January 2022. The recall affected more than 630 units distributed in total between April 2016 and the start of this year.

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Avanos Medical feeding tube The safety event isn't recall in its true meaning: Avanos does not ask medical professionals to return devices back to the manufacturers. Avanos Medical feeding tube Instead, it wants to make sure they're using the devices correctly.

The incorrect placement of the feeding tube can result in damage to vocal cords or the lungs. Avanos was alerted of 23 deaths and 60 injuries in 2015 by the FDA. https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A The incidents were all related to the Cortrak*2 system, which guides the positioning of a feed tube.

These injuries can include respiratory failure, collapsed lungs, lung infection or pleural effusion, as well as holes in the walls of the lungs as well as the esophagus and bowel.

According to FDA, in its March 21 field correct announcement, the Georgia-based company advised users to "confirm placement nasogastric/nasoenteric pipes according to the policies of the institution". They're also required to add the safety note to the system's operating manual and verify with Avanos that they have received the updated.

Avanos has indicated that it will soon issue new labeling for the device. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm This labeling will include the direction to map the tube's location, in accordance with the policies of their facility.

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The FDA has issued a second warning regarding enteral feeding tube use. The FDA issued an safety communication in February, warning healthcare professionals and parents about the risk of strangulation in the event that children are feeding tubes.

The announcement followed two instances of deaths in 2021. The notice was issued following two reports of deaths in 2021. In each case, the tubing system was discovered to have been tied around necks of patients younger than age of 2.

Avanos Medical "While the FDA believes death or serious injuries from strangulation by food set tubing in children is rare Healthcare professionals and caregivers should know that these incidents can and will happen," the FDA noted in the notice.


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