Avea Ventilator Recall Issued Due to Sensor Problems
CareFusion issued an update Monday regarding a recall for their AVEA Ventilator systems used in NICU settings, indicating that the action has been categorized by the FDA as a Class I medical device recall due to the risks patients may face.
The AVEA ventilator recall was originally issued at the beginning of last month, but the manufacturer provided an update on September 30, indicating that hospitals in locations at elevations higher than 5,000 feet above sea level are at a greater risk of experiencing complications or problems with the device.
The FDA has determined that the action qualifies as a Class I recall, which suggests that use of the units poses a reasonable probability of serious adverse health consequences or death.
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The AVEA ventilator is a medical device which offers children in the neonatal intensive care unit (NICU) or adults with complex respiratory diseases improved respiratory care by offering adequate oxygen flow.
The recall was first issued after the manufacturer found errors occurred within the units stemming from a lack of barometric pressure. Healthcare providers have been warned that the ventilators may experience underreporting of oxygen flow to the lungs if used with a neonatal wye hot wire flow sensor, resulting in a higher than expected volume of air to the lungs.
The proportion of air sent to the lungs during use increases with altitude, making hospitals located at 5,000 feet above sea level or higher at greater risk.
The San Diego based medical device company has received at least five complaints concerning problems with the ventilators from facilities located at 5,000 feet above sea level. However, no injuries have been directly attributed to the recall and no deaths have been reported.
The recall advises healthcare providers that the devices do not need to be returned, but specific action should be taken based on which AVEA ventilators are being used.
Comprehensive ventilators can continue to be used with VarFlex single-patient sensors instead of the neonatal hotwire flow sensor. Facilities using standard ventilators should discontinue use and contact customer support. No action is necessary in hospitals located below 5,000 feet below sea level, those settings are least likely to suffer any side effects.
Customers with questions can contact the company by calling the CareFusion Customer Support Center at (800) 562-6018 or by sending an email to SupportCemter@carefusion.com.
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