The FDA has declared a Class I recall for Baxter Healthcare’s Volara system, which poses a risk of respiratory distress in ventilated patients using the product at home.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Product Name: Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit)
Product Model Numbers: PVLIHCBA, M08594, M08594A
Devices Recalled in the U.S.: 268
Dates distributed: May 28, 2020, to April 19, 2022
Date Initiated by Firm: April 26, 2022
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.
Reason for Recall
Baxter Healthcare Corporation, and its subsidiary company Hillrom, are 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)
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.
Who May Be Affected
· Healthcare personnel who recommend use of the Volara system with in-line ventilator adaptor for patients on ventilators in a home-care setting.
· Caregivers who oversee care of a patient who uses the Volara system with in-line ventilator adaptor in a home-care setting.
· People who use a ventilator with the Volara system’s ventilator adaptor in a home-care setting.
What to Do
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:
o Increased breathing rate
o Bluish color around the mouth, inside the lips, or on the fingernails
o Changes in alertness
o 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 Clinical Support team at 800-397-9071 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.
· Return a response form (included with the letter) within two weeks of receipt using the pre-paid return envelope.
Hillrom plans to mitigate this risk by updating the Instructions for Use (IFU) manual to ensure correct usage of the device. Once updated, Hillrom will reach out to customers to set up a home visit with a clinical patient trainer for more training.