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On September 3, 2013, CareFusion voluntarily recalled its AVEA ventilators, and has recently issued an updated to its previously announced voluntary recall. The AVEA ventilator is designed to provide comprehensive critical care ventilation for patients ranging from small children to adults.
The voluntary recall was classified by the FDA as a Class 1 recall, which describes a situation where there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
The underlying reason for the recall relates to barometric pressure sensor compensation when using the neonatal wye hot wire flow sensor. AVEA ventilators may experience an under-reporting of tidal volume if used in conjunction with the neonatal hot-wire flow sensor. Consequently, the patient may receive a higher than expected tidal volume. The error is apparently due to lack of barometric pressure sensor compensation.
The impact of the defect is not felt equally in all geographic areas. Although all AVEA are subject to the 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.
CareFusion issued the following instructions to its customers. Although CareFusion does not require the return of the devices, it 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: