Notes

Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015

Seven years after bad luck for Avanos Medical's feed tube placement system Avanos Medical's enteral feeding tube placement system, the FDA has handed down its most severe designation for a recall of the product.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver and an LCD monitor. The system, when used together with the display monitor, allows live video of the medical feeding tube being placed into a patient's stomach.

Cortrak 2 eternal access system Despite this task, it has been implicated in dozens of patient injuries, leading Avanos to issue an recall earlier in the year of all Cortrak*2 devices used between January 2021 to January 2022. This totals more than 630 devices that were released between April 2016 and the beginning of the year.

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The safety event isn't a recall in the literal sense: Avanos is not asking health professionals to return the device back to its manufacturer but to ensure that they're using them in a safe manner.

Cortrak 2 eternal access system Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or trachea. This could result in severe injury or death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, since 2015, all related to FDA's usage of the Cortrak*2 system to aid in the placement of a feeding tub.

The most common injuries are respiratory failure, lung infections, collapsed lung, pleural effusion, and holes in the walls of the lungs or esophagus, as well as the bowel.

https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical In the March 21 field correction notice, the Georgia-based company advised users to "confirm placement of nasogastric and nasoenteric tubes according to institutional policies," according to the FDA. They're also required to add the safety note to the operating manual of the system and verify with Avanos that they have received the updated.

Avanos has announced that they will soon release a new label for its device. The labeling will be able to include the direction for mapping a tube's location in accordance the policies of their facility.

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The FDA has issued a second warning about enteral feeding tube use. In February the FDA issued the safety alert for parents and healthcare providers regarding the danger of strangulation for children using feeding tubes.

Following two death reports in 2021, this notice was published. A tubing system that wasn't being controlled by caregivers or staff was wrapped around necks and necks of children less than two years old.

"While the FDA believes strangulation by tubing for the feeding tube in children is unlikely to cause injuries or death, caregivers and healthcare providers should be aware of the possibility," the FDA stated in its notice. It also noted that similar incidents could not have been reported yet to the FDA.


Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement