Notes

Avanos Medical is facing a Class I recall due to feeding tube system malfunctions that have resulted in 23 deaths since 2015.

After seven years of failures in Avanos Medical, Avanos Medical’s Enteral Feeding Tube Placement System, the FDA has issued the most significant recall notice ever issued.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver with a display monitor. It can be used in conjunction to provide a live feed that shows the process of inserting a feeding tube into the stomach of a patient. This procedure is carried out with the aim of improving accuracy and reducing complications.

In spite of that mission, it has been implicated in dozens of patient injuries, leading Avanos to issue a recall in January of all Cortrak*2 units used between January 2021 and January 2022--totaling around 630 devices initially released between April 2016 and the start of the year.

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The safety incident is not considered to be a recall. https://www.simmonsandfletcher.com/blog/injuries-incorrect-feeding-tube-placement/ Avanos has asked healthcare providers to not send the devices back to the expense of the manufacturer. Avanos Medical feeding tube But, they would like to ensure they are correctly using the devices.

Incorrectly inserting the feeding tube incorrectly can cause harm to vocal cords and lungs. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all of which were related to FDA's use of the Cortrak*2 system for guiding the installation of a feeding tube.

The reported injuries include respiratory failure, collapsed lung, lung infection the pleural effusion and holes in the lung's walls as well as the esophagus and bowel.

Avanos Medical feeding tube In the March 21 field correction notice, the Georgia-based company reminded users to "confirm the placement of nasogastric as well as nasoenteric tubes according to guidelines of the institution" according to the FDA. Avanos is requesting that users include a safety note in their operating manuals and verify that they've been updated.

Avanos announced that it will soon issue revised labeling for its product. Avanos Medical feeding tube This will include directions to indicate the location of the tube according to their facility's policies.

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The FDA has issued a second warning on enteral feeding tubes this year. In February, FDA released an safety message warning healthcare providers and parents about the potential for strangulation in children who use feeding tubes.

Cortrak 2 eternal access system Avanos Medical feeding tube This notice was issued in response to two deaths in 2021. In both cases the tubing system was inadvertently wrapped around a child's neck while they were not being closely watched by the hospital staff or caregivers.

"While the FDA believes that serious injury or death due to strangulation caused by enteral feeding set tubing for children is extremely rare, healthcare providers and their caregivers must be aware that these events are possible and can happen," the agency said in the announcement warning that similar incidents may not had been reported to the FDA.


My Website: https://medicaldevices.icij.org/events/hkg-cortrak-2-enteral-access-system-eas