A respiratory device that Baxter inherited through its $12.5 billion Hillrom acquisition might work a little too well, a problem that prompted the company to issue an urgent medical device correction.
The Deerfield, IL-based company said that its Volara device may cause oxygen desaturation (a drop in oxygen levels) or lung tissue damage due to over-expansion of the lungs (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 therapy.
Baxter says current patients should continue to use the Volara therapy as prescribed by their doctor. However, caregivers and/or patients should monitor for signs of respiratory distress during Volara therapy when used in line with a ventilator, the company said. Signs of respiratory distress include increased breathing rate; wheezing; bluish color around the mouth, inside the lips, or in the fingernails; changes in alertness; or a drop in oxygen level. If patients do not see improvement after stopping the therapy, they should seek medical attention, Baxter warns. The company said it has received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
Baxter said it plans to mitigate this risk by updating the instructions for use manual to help ensure correct usage of the device. The company also intends to issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue.
Customers with additional questions about the medical device correction notice are asked to call Hillrom customer service support at 800-426-4224, option 3, or Hillrom clinical support at 800-397-9071. Any adverse events experienced with the use of this product may be reported using one of the following options:
- Calling Baxter Product Surveillance at 800-437-5176 Monday through Friday between 8 a.m. and 5 p.m. Central Time.
- Emailing Baxter at: [email protected]
- Reporting to the FDA MedWatch Adverse Event Reporting Program:
- Online: By completing and submitting the report online at https://www.accessdata.fda.gov/scripts/medwatch
- Regular mail or Fax: Download the form from www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.