FDA MedWatch - Volara System by Baxter Healthcare

U.S. Food and Drug Administration sent this bulletin at 06/24/2022 08:15 AM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Volara System by Baxter Healthcare: Class I Recall - Due to Risk of Respiratory Distress In Ventilated Patients During Home Use

AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonology, Home Care

ISSUE: Baxter Healthcare Corporation is recalling the Volara system because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risks to affected patients include:

Choking on mucus or other airway secretions
An infection in the lungs (pneumonia) that prevents oxygen from getting to the blood (respiratory failure)
Brain injury caused by lack of oxygen to the brain (hypoxia)
Death

The risk of serious injury or death is more significant in home-care settings if the caregivers are not trained properly, the device is not connected properly, or if the caregiver is not prepared to address any issues that may arise caused by use of this device.

There has been one complaint and one injury, as well as two deaths, associated with the use of this device.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The Volara system is intended to help people clear mucus out of their airways, expand the lungs, and to treat or prevent a partial collapsed lung (pulmonary atelectasis). The system’s in-line ventilator adaptor component makes it possible for it to be used together with a ventilator (in-line) in home-care settings.

RECOMMENDATIONS: On April 26, 2022, Hillrom, a Baxter company, issued an Urgent Medical Device Correction letter to customers. Actions to be taken by customers includes:

Continue use of Volara therapy as prescribed by the doctor.
Ensure suction unit is prescribed by the doctor for home use alongside the Volara unit to enable caregiver to suction mobilized secretions.
Monitor for signs of respiratory distress such as:
- Increased breathing rate
- Wheezing
- Bluish color around the mouth, inside the lips, or on the fingernails
- Changes in alertness
- A drop in oxygen saturation level
Stop use of Volara therapy immediately if signs of respiratory distress occur. If signs of respiratory distress do not improve, seek medical attention.
Contact the company's Clinical Support team for questions or assistance with Volara therapy used in-line with a ventilator. Support can be provided via phone or through an in-person visit with a clinical patient trainer.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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