Baxter Healthcare Corporation Volara System Lawsuits

Volara System Death Lawsuits

According to a recall announcement issued by the U.S. Food and Drug Administration (FDA), both the Volara system with in-line ventilator adaptor (OPTIMUS Handset 2) and the Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit) have been recalled due to respiratory distress risks when used at home. The FDA identified the recall as a Class I recall, which is the most severe type of recall. The recall was classified as a Class I recall because the medical devices may cause severe injuries or death.

The FDA’s announcement states that about 270 units are affected by the recall. The affected medical devices have one of the following product model numbers: PVLIHCBA, M08594, M08594A, and were distributed for May 28, 2020, until April 19, 2022.

The Volara system was developed to help patients remove mucus out of their airways, prevent a partially collapsed lung (also known as pulmonary atelectasis), and expand the patient’s lungs. The Volara system’s in-line ventilator adaptor component allows the components to be used with an in-line ventilator in-home care environments.

Baxter Healthcare Corporation’s subsidiary company Hillrom, has recalled its Volara system due to reports of the in-line ventilator adaptor preventing home-use patients from receiving adequate levels of oxygen from their ventilators. The hazards to affected patients can include:

• Death;
• Choking on mucus;
• An infection in the lungs (pneumonia); and
• Brain injury due to a lack of oxygen delivered to the brain (hypoxia).

The risk of severe injury or death is more consequential in in-home care environments, especially when the caregivers have not received adequate training, the ventilator device is not connected correctly, or the caregiver is unable to address issues that arise with the device.

There have been at least one injury and two deaths connected to the use of this device.

On April 26, 2022, Hillrom issued an Urgent Medical Device Correction letter to its customers with the following actions to be taken by customers:

• Use the Volara therapy as prescribed by your doctor.
• Ensure your doctor has prescribed the suction unit for at-home care.
• Look for signs of respiratory distress such as:
  • Wheezing
  • Increased breathing rate
  • Bluish color on the fingernails, inside the lips, and around the mouth
  • Differences in alertness
  • A decrease in oxygen saturation level
• Halt the use of Volara therapy as soon as signs of respiratory distress appear.
• If the signs of respiratory distress will not improve, seek emergency medical attention.
• Contact the Volara Clinical Support team for questions or help with Volara therapy used in-line with a ventilator.

Hillrom intends to eliminate the risk by revising its Instructions for Use (IFU) manual to ensure the device’s correct usage is included. Once the IFU is updated, Hillrom will contact its customers to schedule a home visit with a clinical patient trainer for additional training.

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