Notes

Avanos Medical faces Class I recall due to the feeding tube system's connection up to 23 deaths.

Seven years after bad luck for Avanos Medical's enteral feeding tube placement device Avanos Medical's enteral feeding tube placement system, the FDA has issued the most serious of designations for a recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with the capability of displaying a screen monitor. Cortrak 2 eternal access system The system, when used together with the display monitor, allows live video of the medical tube being placed into the stomach of a patient.

Avanos Medical feeding tube Despite this task, it has been linked to dozens of patient injuries, leading Avanos to announce an recall earlier in the year of all Cortrak*2 devices between January 2021 to January 2022. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding This totals more than 630 devices that were distributed between April 2016 until the beginning of the year.

RELATED
A tiny widget, promising greater safety, creates chaos for tube feeders
The safety incident isn't a recall in the literal sense: Avanos is not asking healthcare providers to send the device back to its manufacturer but to ensure that they're using the devices correctly.

Incorrectly inserting a feeding tube can cause damage to the vocal cords, lungs, or trachea. This could result in serious injuries, or death. According to the FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all related to FDA's usage of the Cortrak*2 system for guiding the installation of a feeding tube.

There are several injuries that have been reported like respiratory failure, collapsed lung, lung infection.

The FDA has reminded patients of the need to verify the placement of a nasogastric or nasoente tube according to their institution policies in the March 21 field correction notice. Cortrak 2 eternal access system The company also asked users to attach the safety warning to the operating manual of the system and confirm with Avanos that they have received the update.

feeding tube placement Avanos announced that it will shortly provide updated labels for the device that will include a direction to map out the tube's location in accordance the guidelines of their facility before making use of the system to assist to install the tube.

RELATED
FDA wants Philips to replace, fix or reimburse all recall ventilators
This is the FDA's second warning about enteral feeding tube use. The FDA issued a safety announcement in February that warned healthcare professionals and parents about the risk of strangulation in the event that children are feeding through tubes.

The notice was issued as a result of two deaths in 2021. The notice came in the wake of two reports of deaths in 2021. In each case the tubing system was found to be tied around necks of patients younger than age 2.

"While the FDA believes that the risk of serious injury or death due to strangulation caused by enteral feeding set tubing in children is uncommon, healthcare providers and their caregivers must be aware of the fact that these incidents can and do occur," the agency said in its notice, suggesting that other similar cases may not yet had been reported to the FDA.


Website: https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/