Notes

Avanos Medical faces Class I recall because of feeding tube connection that led to 23 deaths.

Seven years after bad luck for Avanos Medical's feed tube placement device The FDA has given the most serious of designations for recalls of the product.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm It also comes with a display screen monitor. The system gives a live stream of medical tube feeding that are inserted into the stomachs of patients or small bowels. This allows for the advancement of the precision of tip placement and the reduction of complications.

feeding tube placement Despite that task, however, the system has been implicated in the occurrence of numerous injuries to patients which led Avanos to issue an recall earlier in the year of all Cortrak*2 units used between January 2021 and January 2022, totalling more than 630 devices that were released between April 2016 and the start of this year.

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The safety incident isn't a recall in the strict sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer, but rather to ensure they're using them in a safe manner.

Avanos Medical feeding tube An incorrectly placed feeding tube could cause damage to vocal cords and lungs. It could also cause serious injury or even death. Avanos has reported 23 deaths and 60 injury cases since 2015 as per the FDA. All of this was due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

There are several injuries that have been reported including respiratory failure, collapsed lung and lung infections.

The FDA advised users of the need to verify that they have placed a nasogastric tube in accordance with their institution policies in the March 21 field correction notice. Avanos has asked users to add a safety warning to their operating manual and to confirm they've updated their manuals.

Avanos indicated that it will shortly issue new labels to the device. These will include the instructions for how to place a tube, in accordance with the company's policies.

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The FDA has issued a second warning of the year for tube feeding through the stomach. In February, FDA released a safety announcement to healthcare providers and parents about the possibility of strangulation in children who use feeding tubes.

Avanos Medical In the wake of two deaths in 2021, a notice was sent. In each instance the tubing system was found to accidentally wrap around the neck of a patient younger than 2 when they weren't directly observed by their staff members or caregivers.

"While the FDA considers that strangulation caused by tubing for the feeding tube in children is not likely to result in death or serious injury, caregivers and healthcare providers should be aware of this potential risk," the FDA stated in the notice. The FDA also stated that similar incidents could not have been reported to the FDA.


Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/