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| CareFusion's Avea ventilator--Courtesy of CareFusion |
CareFusion's Avea ventilator was just hit with a Class 1 recall by the FDA, meaning the agency believes there is a reasonable probability that exposure to or use of the 15,905 violative devices "will cause serious adverse health consequences or death."
All models of the Avea are affected by the recall.
The FDA blamed the problem on device design in the recall notice, saying "a pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator."
In a statement, CareFusion said it is not aware of any patient injuries that have occurred as a result of the problem, and that it was a voluntary action, like most other recalls. When the FDA becomes aware of corrective actions, it puts them in its recall database and designates them into one of three categories based on severity.
CareFusion said it has a sent a letter to customers of all models of the Avea informing them of the potential risk caused by the malfunctioning pressure transducer and telling them what actions should be taken in response. It tells customers that they will be contacted by the company, and advises them to remove affected ventilators from service if the problem can not be fixed by turning the machine off and then on again.
There are 5,670 affected units of the ventilator in the U.S. The rest are distributed widely throughout the world. CareFusion said the recall covers all Avea ventilators manufactured between July 1, 2011 and March 15, 2015. The FDA listed the affected serial numbers in the recall notice.
The recall notice says the Avea's main function is "to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas."
CareFusion sells ventilators for several purposes such as transport, home care, and in the case of the Avea, critical care. The company touts the Avea's patient monitoring, precision gas delivery and communication capabilities.
Since 2011 there have been 22 Class 1 recalls of continuous ventilators, including 6 recalls of devices manufactured by CareFusion. Some of the most common ventilator problems reported to the FDA include error messages, incorrect or inadequate test results, and inoperability of the device.
Transducer failure is a relatively rare (and serious) occurrence, with 11 reports in the FDA's adverse event database.
- read the recall notice
- read the CareFusion's statement
- here's CareFusion's letter to customers
Editor's Note: This article has been updated with additional information from CareFusion.