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Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If used In Conjunction With Neonatal Hotwire Flow Sensor
AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: CareFusion announced a voluntary recall of AVEA ventilators regarding barometric pressure sensor compensation when using the neonatal wye hot wire flow sensor. AVEA ventilators may experience an underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor. The patient may receive a higher than expected tidal volume. The error is due to lack of barometric pressure sensor compensation. BACKGROUND: While all AVEA ventilators fall under this voluntary recall, hospitals in locations at high elevations (higher than 5,000 feet above sea level) that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error. The level of underreporting between displayed flow and actual flow increases proportionately with altitude. CareFusion has received five complaints from a facility that was operating in the neonatal patient care settings and was located higher than 5,000 feet above sea level. No injuries have been directly attributed to this issue. RECOMMENDATION: CareFusion advises its customers in locations higher than 5,000 feet above sea level using the AVEA ventilator in neonatal patient care settings with a wye hot wire flow sensor to take one of the following actions: Customer inquiries related to this action should be addressed to the CareFusion Customer Support Center at 1-800-562-6018 between the hours of 7:00 am to 4:30 pm PDT, Monday through Friday, or contact the company by email at SupportCenter@xxxxxxxxxxxxxx and the support center will follow up with customers.
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Read the MedWatch Safety Alert, including links to the Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370566.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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