Baxter (NYSE: BAX) announced that it has issued an Urgent Medical Device Correction for its Volara System for Pulmonary Oscillation and Expansion (OLE) therapy.
Baxter’s warning 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 decreased oxygen levels (desaturation in oxygen) that can lead to lung injury – expansion (barotrauma) in the home care setting.
Baxter is voluntarily releasing the urgent medical device correction with the knowledge of the FDA, the company said in a press release.
According to the release, the potential events could occur when using Volara inline with a ventilator with the required Volara Ventilator Adapter 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 inline with a ventilator. Baxter has received a report of a patient experiencing oxygen desaturation while using Volara inline with a ventilator in a home care setting.
Baxter also plans to mitigate the risk associated with Volara by updating the user instruction manual to ensure correct use of the device. Once this is updated, Baxter will contact patients to arrange a home visit with a trainer to provide additional training. The company will also send a follow-up letter to patients to communicate more details on the steps taken to resolve the issue.
Urgent Medical Device Correction applies to Volara PVL1HCBA System model numbers; M08594; and M08594A with in-line FAN adapter (MODULE M07937, OPTIMUS HANDSET 2) or Volara patient circuit kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT which includes M07937).