Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer

[Posted 05/27/2015]

AUDIENCE: Risk Manager, Critical Care Medicine, Anesthesiology

ISSUE: The recall is in response to a potential malfunction of an AVEA ventilator-specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.

The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015.  A list of affected model and serial numbers is available at the CareFusion website .

The company has notified customers of the recall with an urgent recall letter.

BACKGROUND: The AVEA ventilator is only used in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients.

RECOMMENDATION: CareFusion does not require the return of affected AVEA ventilators.

If an AVEA ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support at the contact information listed below to report the issue.

Customer inquiries related to this action should be addressed to the CareFusion Recall Support Center at 1.888.562.6018 or email SupportCenter@carefusion.com between the hours of 6:30 a.m. to 5:00 p.m. PDT.

For technical support or to report a problem, please contact CareFusion Technical Support at 1.800.231.2466 or email Support.Vent.US@carefusion.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/27/2015 - Firm Press Release - CareFusion]
[05/27/2015 - Product Labels - FDA