According to a release by the Food and Drug Administration (FDA), Baxter International Inc. announced it has issued an Urgent Medical Device Correction for the Volara System (home care).
This correction has been issued to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment.
These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021.
As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention. Baxter received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
In addition, Baxter will mitigate this risk by updating the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter will contact patients to arrange for a trainer to conduct a home visit to provide additional training. Baxter will also issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue.
This Urgent Medical Device Correction applies to Volara System model numbers PVL1HCBA; M08594; and M08594A with in-line VENTILATOR adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that include M07937).
The Volara System is distributed in the United States.
Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.