Overview
After reports of two deaths related to Baxter’s Volara ventilator system, the Food and Drug Administration issued a recall of this device and categorized it as a Class I event.
Baxter learned that their devices may interfere with the oxygenation of ventilators in outpatient settings, which led them to recall 259 Volara circuit kits and 9 other Volara units in the United States. This chain of events was triggered by the death of two patients and an injury of one.
Hillrom is the associated company that released these products into the market. Note that Baxter acquired Hillrom in 2021 for $10.5 billion. The goal of this acquisition was to expand Baxter’s digital health department.
A Class I event recall by the FDA
Hillrom is a MedTech company that worked on the Volara product to allow people to get oscillation and lung expansion in an outpatient setting.
By inflating the lungs, the system supposedly prevents their partial collapse and gets rid of mucus stuck in the airways. Adding an in-line ventilator adaptor to the system allows for its use at home.
According to officials from Baxter, patients who use the in-line adaptor are at risk of not receiving enough oxygen. This statement stems from one report that demonstrated low blood oxygen levels while using the in-line adaptor at home. The statement was released at the beginning of this month. Jump forward a few weeks, the FDA referenced the death of two patients and the injury of one.
The FDA categorized the recall as a Class I event. This means the Volara device poses serious risks of injuries and even death.
Complications listed by the FDA include:
- Suffocation due to mucus accumulation
- Respiratory failure due to low blood oxygen levels
- Irreversible brain damage due to tissue anoxia
- Death by any of the reasons listed above
The FDA wrote in the recall notice that “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.”
Once this news became public, Baxter released a statement encouraging patients to keep using Volara therapy but take precautions against the risks.
The recommendations of Baxter included:
- Ensuring that the doctor prescribed the suction unit with the Volara system
- Monitoring patients for any signs and symptoms of respiratory failure (e.g., tachypnea, wheezing, low blood oxygen levels)
Baxter’s Hillrom announced its plans on creating an updated version of the device’s instruction manual. They will also schedule a home visit to patients with a clinical patient trainer. The goal of these steps is to mitigate the risks and provide training to outpatient customers.
Takeaway message
The FDA issued a Class I event recall of the Volara ventilators developed and distributed by Baxter’s Hillrom. The company took several measures to ensure that the reported incidents will not occur again.
The upcoming few weeks should tell us whether Baxter is going to take any further measures and how patients respond to this news.
