CareFusion recalled its AVEA ventilators regarding barometric pressure sensor compensation when using the neonatal wye hot wire flow sensor. Specifically, 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.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
All AVEA ventilators are subject to this recall. However, 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 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.
Hospitals located higher than 5,000 feet above sea level using the AVEA Comprehensive ventilator may continue to use the ventilator using the VarFlex single-patient use sensor (CareFusion part number 50000-40038), but should discontinue use of the neonatal hotwire flow sensor until the software correction has been installed. Hospitals located higher than 5,000 feet above sea level using the AVEA Standard ventilator should not use it in neonatal patient care settings. Hospitals located below 5,000 feet above sea level need take no action at this time.
See the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe