San DIego, Calif.-based CareFusion Corp. has updated its recent recall of its Avea ventilaros.
The company said hospitals located in high-altitude areas that use its Avea ventilators in neonatal-care settings are at greatest risk of a potential error in an update of the company's voluntary Class I recall that was issued on Sept. 3.
The recall was classified as a Class I by the U.S. Food and Drug Administration. A Class I recall is defined as having a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
The recall involves Avea ventilators when used with the neonatal wye hot wire flow sensor, which the company said may under-report tidal flow volume as the result of a lack of barometric pressure sensor compensation. This could lead to a patient receiving higher-than-expected tidal volume. CareFusion in a statement said that the level of underreporting between displayed flow and actual flow increases proportionately with altitude. High-altitude settings include those located more than 5,000 feet above sea level.
The company said it has received five complaints from a facility operating in a neonatal setting at a high altitude facility but no injuries have been directly attributed to the issue.
Hospitals using the Avea comprehensive ventilator should stop using the neonatal hotwire sensor until a software correction is installed and use a VarFlex single-patient use sensor in the interim, CareFusion said. Customers using the Avea standard ventilator should stop using it in neonatal settings and contact CareFusion's customer support.
The company said hospitals located at less than 5,000 feet above sea level aren't required to take any action at this time.