Notes

Avanos Medical is facing a Class I recall due to feeding tube system malfunctions that have led to the deaths of 23 patients in the last year.

Seven years after adversity for the Avanos Medical Enteral Feeding Tube Placement System, the FDA has issued its most severe designation for the recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver, a monitor for display as well as an electronic receiver. When used together the system provides a live feed of the process of inserting an medical tube for feeding into the stomach of a patient, or in the small bowel with an intention of improving the accuracy of the tube's placement and reducing complications.

Avanos Medical Avanos began an earlier this year for all Cortrak*2 equipment in use between Jan 2021 to Jan 2022. There were more than 630 units originally distributed from April 2016 through the beginning.

The safety event isn't a recall , in the literal sense: Avanos is not asking healthcare professionals to send the device back to its manufacturer instead, it's a way to make sure that they're using them correctly.

A feeding tube that is not properly placed can cause harm to vocal cords as well as the lungs. It may also cause grave injury or even death. Avanos was notified of more than 60 injuries and 23 deaths in the year 2015 by the FDA. These incidents were all connected to the Cortrak*2 system that guides the installation of the feeding tube.

The most common injuries include respiratory failure and collapsed lung and lung infections, pleural effusions and holes in the walls, esophagus, bowel, and lungs.

In its March 21 field correction notice, the Georgia-based company warned users to "confirm the placement of nasogastric as well as nasoenteric tubes according to the policies of the institution," according to the FDA. Avanos Medical Avanos advised users to attach the safety notification to the operation manual of the system and then confirm that they have notified Avanos that the update was received.

Avanos said it would soon release updated labels for the device. https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ These will include the direction of how to place a tube in line with their policies.

The FDA has issued a second caution regarding the use of an enteral tube for feeding use. The FDA released safety communications in February, warning parents, healthcare professionals, and children about the possibility of strangulation from tubes feeding food.

The announcement came in the wake of two reports of death in 2021. In both instances, a tubing device was discovered to be accidentally wrapped around neck of a patient who was less than two years old, while they were not supervised by their caregivers or hospital personnel.

Avanos Mediacal Cortrak 2 "While the FDA believes strangulation with feed set tubing used for enteral feeding in children is not common healthcare professionals must be aware of the possibility of this happening," the agency stated in the announcement. Avanos Medical feeding tube This suggests that similar cases could not have been reported to FDA.


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