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Volara System Recalled

man-g4698b989e_640-e1655155803670A broad range of chronic conditions are treated with the Volara System, which provides continuous positive expiratory pressure (CPEP) to expand your lungs and airways, along with continuous high-frequency oscillation pulses to free mucus plugs and make it easier to cough and breathe less effortfully. However, if you use the Volara System, it’s important to be aware that its manufacturer, Baxter International Inc., issued an Urgent Medical Device Correction for the Volara System and then a recall. This is a home care system prescribed by doctors when a patient needs a ventilator in the home environment. Unfortunately, it’s been found that use of the system comes with a possible risk of oxygen desaturation, as well as the danger of overexpansion resulting in lung tissue damage. If you were injured or a loved one was killed due to the malfunctioning of the Volara System, you should give the seasoned product liability lawyers of Moll Law Group a call. You may have grounds to sue for damages, and it is important to seek counsel.

Give Moll Law Group A Call About Injuries From Defective Products

Baxter voluntarily issued the Urgent Medical Device Correction after receiving a report of a patient suffering from oxygen desaturation while using the device at home. The device was recalled in a class 1 recall because the device poses serious risks such as lung infection that restricts oxygen to the brain, brain injury such as hypoxia, death, and choking on mucus.

Initially caregivers and patients were warned to continue to use Volara therapy as prescribed, but were supposed to monitor for respiratory distress signs such as an increase in breathing rate, bluish color around the mouth or inside it, wheezing, or changes in alertness, when using it. Patients were told potential issues could occur when using the device with a ventilator and adaptor or the patient circuit kit oscillation and lung expansion therapy.

Baxter intends to update its user manual in order to mitigate the risk. It also plans to contact patients to schedule appointments for trainers to come to their home and provide further training.

Meanwhile, you should be attentive to the fact that the correction applies to the following Volara System model numbers: PVL1HCBA; M08594; and M08594A when used with in-line ventilator adaptors M07937 MODULE, OPTIMUS HANDSET 2 or the Volara Patient Circuit Kit, which is M08473 OPTIMUS OLE AC PAT, and the Circuit Kit that includes M07937. If you or a loved one experiences an adverse event because of the Volara system, you should report it to Baxter Product Surveillance.

When a patient is injured by a malfunctioning ventilator system, he or she may have grounds to sue for damages in a product liability lawsuit. Each state has its own rules regarding the theories under which the victim of the defective product can recover damages. These theories may include strict liability, breach of warranty, breach of contract, and negligence. When strict liability applies, our lawyers will not need to prove that the manufacturer’s conduct fell below the standard of care, but instead will seek to show: (1) the product was defective, (2) the defect caused you injuries that resulted in (3) actual damages.

If a loved one died due to a Volara or other ventilator system failure, you may have grounds to bring a wrongful death lawsuit for damages. It’s important to choose a lawyer who is able to evaluate whether any parties aside from the manufacturer might also bear responsibility for a ventilator failure. For example, in some cases, there may be a medical malpractice component.

Call the Product Liability Lawyers of Moll Group

If you or a loved one were harmed in connection with a Volara device, you should call the seasoned Chicago-based product liability lawyers of Moll Law Group. We represent plaintiffs and their families around the country. Please complete our online form or give us a call at 312.462.1700.

 

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