On June 1, 2022, Baxter International Inc. announced an Urgent Medical Device Correction for its Volara System (home care). This Volara recall was voluntary. Baxter inherited the Volara device when it acquired Hillrom for $12.5 billion.
According to the U.S. Food and Drug Administration (FDA), Baxter voluntarily issued the Urgent Medical Device Correction, with the knowledge of the FDA. The point of the Volara recall is to reinforce important safety information. According to a posting on the FDA website on May 30, 2022, the Volara recall is a Class 1 recall.
According to Baxter, the Volara System for Oscillation & Lung Expansion (OLE) Therapy combines three key therapies:
- Continuous Positive Expiratory Pressure (CPEP) treats and helps prevent pulmonary atelectasis by combining continuous positive pressure with aerosol medication, to help expand and hold the airways open
- Continuous High-Frequency Oscillation (CHFO) delivers continuous pulses of positive pressure, a form of pneumatic chest therapy, combined with aerosol medication to mobilize mucus from the small airways to the large airways and treat retained secretions
- Aerosol delivery, integrated with CPEP and CHFO, helps loosen secretions, maximizing treatment efficiency
Medical professionals prescribe the use of the Volara device in line with a ventilator. In announcing the Volara recall, Baxter warned of two potential medical conditions: oxygen desaturation (a drop in oxygen levels) or barotrauma (lung tissue damage, caused by overexpansion of the lungs) in the home care environment. Baxter reported that it has received one report of oxygen desaturation in a patient who was using the Volara device in line with a ventilator in a home care environment.
According to Baxter’s Urgent Medical Device Correction, current users can continue to use Volara therapy under a doctor’s prescription, patients and caregivers who use Volara in line with a ventilator should monitor for signs of respiratory distress. Signs of respiratory distress include the following:
- increased breathing rate
- blue color around the mouth, lips, or fingernails
- changes in alertness
- drop in oxygen level
The Urgent Medical Device Correction applies to the following Volara System model numbers:
- M08594A with in-line VENTILATOR adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that includes M07937).
Baxter indicated that it will update the instruction manual and issue a follow-up letter to patients. Customers with questions about the device can contact Hillrom customer service.
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