The warning from Baxter for the Volara system — manufactured by Hillrom, which Baxter acquired for $12.5 billion last year — reinforces important safety information regarding a possible risk of the decrease in oxygen levels (oxygen desaturation) that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment.
Baxter is voluntarily issuing the urgent medical device correction with the knowledge of the FDA, the company said in a news release.
According to the release, the potential events could occur while using Volara in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit OLE therapy.
Current patients should continue to use Volara therapy as prescribed by their physician, while caregivers and/or patients should monitor for signs of respiratory distress during Volara therapy when used in line with a ventilator. Baxter received one report of a patient experiencing oxygen desaturation while using Volara in line with a ventilator in the home care environment.
Baxter also plans to mitigate the risk associated with Volara by updating the instructions for use manual to ensure the correct usage of the device. Once that is updated, Baxter will contact patients to arrange for a trainer to conduct a home visit to provide additional training. The company will also issue a follow-up letter to patients to communicate further details on the actions being taken to address the issue.
The 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).