Volara

2022

Recall of defective equipment due to which at least 2 people died

On June 23, 2022, Baxter announced that it was recalling defective breathing equipment recall of the Volara pulmonary therapy system for oscillation therapy and pulmonary dilation, due to which at least 2 people died. The company plans to reduce the risk associated with the device by updating the instructions for use to ensure the correct use of the device.

For June 2022, there was one complaint and one injury, as well as two deaths related to the use of the Volara pulmonary therapy system. Baxter began the recall on April 26, 2022, the devices distributed between May 28, 2020 and April 19, 2022 are affected, a total of 268 devices are recalled in the United States.

Recall of defective equipment that caused at least 2 deaths

Volara is manufactured by Hillrom, which Baxter acquired for $12.5 billion in 2021. The device presents a possible risk of lowering oxygen levels (desaturation of oxygen), which can lead to damage to the lung tissue due to excessive expansion (barotrauma) in home care conditions. Such events can occur when Volara is used in combination with a ventilator with the necessary Volara adapter or Volara patient loop kit for OLE therapy.

According to a notice from the Food and Drug Administration (FDA), risks to affected patients include choking on mucus or other airway secretions. The document says that an infection in the lungs, which prevents oxygen from entering the blood, causes brain injury, which occurs due to a lack of oxygen in the brain (hypoxia). The department said the risk of serious injury or death is more significant in home care settings if users are not properly trained or the device is not properly connected.

Baxter instructed current patients to continue using Volara therapy as directed by a physician. Caregivers or patients should monitor for signs of impaired breathing during Volara therapy when used in combination with an apparatus. MECHANICAL VENTILATION The company intends to contact patients to arrange for the instructor to travel home to conduct additional training and to issue a follow-up letter to patients to report more details information about the actions taken to address the issue.^[1]

Baxter warned of marriage in its devices to treat lung disease at home

On June 2, 2022, Baxter issued an urgent warning regarding the operation of Volara's Oscillation and Lung Expansion (OLE) system. It was developed by Hillrom, which Baxter acquired for $12.5 billion in 2021.

Baxter's warning regarding the Volara system confirms earlier information regarding the possible risk of oxygen reduction (oxygen desaturation), which can lead to damage to lung tissue due to excessive expansion (barotrauma) in home care.

The detected problem can occur if the Volara system is connected to a ventilator - one of the few devices that can be used to provide therapy. In some cases, conducting therapy with a built-in ventilator can cause them to expand excessively, which can lead to injuries, the company said.

Baxter said it received at least one report of a patient experiencing oxygen desaturation while using the device in tandem with a ventilator in a home care setting.

Despite the risks identified, the company said patients can continue to use the devices as intended, although users and caregivers should watch for signs of impaired breathing, such as rapid breathing, wheezing, bluish color around the mouth or nails or sudden drowsiness. If any of these symptoms occur, patients should immediately stop using the Volara system and seek medical attention if the condition does not improve.

Baxter said it is also working to update the system's instructions for use to make its correct use clearer. As this update is implemented, the company will also direct customer service agents to train users and their caregivers to use the device properly at home.^[2]

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