Volara Home Care Oxygen Systems May Fail to Provide Sufficient Oxygen and Could Cause Lung Damage, FDA Warns
Baxter and the FDA warn the systems could cause overexpansion of the lungs, leading to lung damage and oxygen deficiency.
Federal health officials indicate that certain Volara home care oxygen systems have the potential to malfunction, resulting in a lack of oxygen delivery and an increased risk of lung tissue damage for users.
The FDA issued the Volara home oxygen system warning on June 2, recommending patients to stop using the ventilators if they experience signs of respiratory distress, and to seek immediate medical attention if the symptoms do not subside.
To date, an official Volara oxygen system recall has not been issued, however the FDA been notified of one injury report of a patient experiencing oxygen desaturation while using the Volara device in a home care environment.
The Volara Systems are used for Oscillation and Lung Expansion (OLE) therapy and are designed to be used in the home setting to provide alternating cycles of Continuous Positive Expiratory Pressure (CPEP) and Continuous High Frequency Oscillation (CHFO), combined with aerosol delivery.
According to the warning, when the Volara system is used in line with a ventilator, the device can allow an overexpansion of the lungs that may result in oxygen desaturation, which is a condition that causes a dangerous decrease in oxygen levels. In this event, users could experience signs of respiratory distress including increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails and changes in alertness.
Following a report of a patient suffering oxygen desaturation after using the Valora System, Baxter International Inc. issued an Urgent Medical Device Correction on June 1, warning patients to immediately stop using the devices if they experience symptoms of respiratory distress.
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The warning involves Volara System with model numbers PVL1HCBA, M08594, and M08594A with in-line ventilator adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that include M07937).
Baxter announced it will be releasing an update to the Instructions For Use (IFU) manual to help ensure correct usage of the device. Once the updated IFU is available, Baxter indicates it will contact patients to arrange for a trainer to conduct a home visit to provide additional training.
Customers with additional questions or concerns regarding their Volara systems are being encouraged to contact Hillrom Customer Service Support at 800-426-4224 or Baxter Product Surveillance at 800-437-5176.
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