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High Altitudes Cause More Problems with Recalled CareFusion Avea Ventilators

Oct 1, 2013

Avea ventilators, which were part of a Class I recall earlier this year, are particularly prone to malfunctioning in high-altitude areas, according to CareFusion Corp., maker of the devices.

According to a release from the medical device maker, the U.S. Food and Drug Administration (FDA) issued the initial Avea ventilator recall on Sept. 3, confirming the company's belief that the recall deserved the Class I designation.

The FDA's Class I recall is reserved for medical devices or pharmaceutical drugs that carry a significant risk of causing serious injuries or death if used in patient care.

In the initial recall, CareFusion noted that complications could arise while using the Avea ventilators due to a problem with the barometric pressure sensor compensation when the device was used with the neonatal hotwire flow sensor. This defect could result in an underreporting of tidal volume if the device were used in conjunction with the neonatal hotwire flow sensor, according to an updated company statement.

In its update on the recall issued in early September, CareFusion notes that complications most likely will happen in hospitals situated in high-altitude areas. The company said hospitals higher than 5,000 feet in elevation face the greatest risk of the error that prompted the initial recall notice. According to the recall statement, "the level of underreporting between the displayed flow and the actual flow increases proportionately with altitude."

CareFusion says it has received five reports of complications with the Avea ventilator from hospitals in high-altitude settings. No injuries were linked directly to complications caused by the Avea ventilators used in the neonatal setting, the updated statement notes.

The company has issued specific instructions to hospitals using the Avea ventilators in neonatal settings. CareFusion says it will issue a software update to compensate for the high-altitude settings of some hospitals when using the neonatal hotwire flow sensor. Hospitals should avoid using the Avea ventilators in this way until the corrections are made, the statement notes.

Also, "[i]f using the Avea Standard ventilator, discontinue use in neonatal patient care settings and contact CareFusion customer support," CareFusion notes.

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