A device that’s meant to clear out and expand the lungs may actually go too far, resulting in a potentially dangerous decrease in overall oxygen levels, Baxter said this week.
In light of that discovery, the devicemaker has put out an urgent medical device correction for its Volara system for oscillation and lung expansion therapy, focusing specifically on those devices used in a home care environment.
The Volara system provides a trio of respiration treatments. It simultaneously helps expand the lungs and move mucus out of them and into the large airways, all while delivering aerosol medication to the lungs to smooth out both processes.
The system arrived under Baxter’s purview late last year when the Illinois-based medtech completed its outsized acquisition of Hillrom, the original maker of the device.
The recently discovered safety issue can occur when the Volara system is connected to a ventilator—one of a handful of accessories that can be used to deliver its treatments. In some cases, according to Baxter, performing the therapy with an inline ventilator can lead to an overexpansion of the lungs, which could, in turn, cause a decrease in oxygen levels—known as oxygen desaturation—or possible damage to the lung tissue.
So far, Baxter said it has received one report of a patient experiencing oxygen desaturation while they were using the device in tandem with a ventilator in their home care environment.
Despite the identified risks, the company said patients at home can continue to use the devices as prescribed, though users and caregivers should keep an eye out for signs of respiratory distress, which include rapid breaths, wheezing, bluish coloring around the mouth or fingernails or a change in alertness.
If any of those symptoms arise, patients should stop using the Volara system immediately and seek medical attention if they don’t improve.
Baxter said it’s also currently working on updating the system’s instructions for use to make its correct usage more clear. As it rolls out that update, the company will also send out customer service agents to train users and their caregivers in the proper use of the device in the home.
Baxter initiated the safety event at the end of April. The FDA has already handed down its most serious classification to the event, naming it a Class I recall—the second for Baxter this year.
According to the agency’s database, the recall spans just 268 units currently in use across the U.S.: 259 circuit kits manufactured since the end of February 2020 and nine handsets manufactured since October 2019, all of which are used to connect a ventilator to the Volara device.