Baxter International Inc has issued an Urgent Medical Device Correction for the Hillrom Volara System (home care) over a possible risk of oxygen desaturation or lung injury due to over-expansion (barotrauma) in the home care environment, according to a June 1, 2022 company news announcement.
Oxygen desaturation and barotrauma 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 (OLE) therapy, according to Baxter.
The company said that it received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.
According to the FDA’s website, the agency labeled this a Class I recall on May 30, 2022. The FDA lists two separate recall events (ID 90061): the first (Z-1138-2022) for 259 units of the Volara System’s in-line ventilator adaptor manufactured since February 28, 2020, and a second (Z-1139-2022) for 9 units manufactured since October 17, 2019.
Both recall notices report that “There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.”
The company said the following model numbers are affected: 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).
Baxter advises current patients to continue their Volara therapy as prescribed by their physician. “Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator. Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention.”
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.