This week, medical device maker CareFusion provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA ventilators.
The AVEA ventilator is used in hospitals and health care facilities and is intended for continuous breathing support for neonatal through adult patients. 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, according to news release.
If the malfunction occurs, alternate ventilation support will be required to reduce the potential of hypoxemia (low oxygen) or hypercapnia (increased carbon dioxide in the blood).
The global recall involves AVEA ventilators manufactured and distributed from July 1, 2011 to March 15, 2015. CareFusion learned of the issue through customer reports identifying Extended High Peak or Circuit Occlusion alarms. A full list of affected model and serial numbers is available on the CareFusion website, which has information about how to locate the serial number. The ventilators were distributed in more than 90 countries around the world.
The recall was designated a Class I recall by the Food and Drug Administration (FDA). Class I is the FDA’s most serious recall category, reserved for situations where the FDA believes there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. To date, no report of patient injury has been received related to this issue, according to the news release.
CareFusion said it will continue to work diligently with customers and regulatory authorities to resolve this issue in a timely manner. The company has notified customers of the recall with an urgent recall letter. The CareFusion Recall Support Center is contacting global customers via telephone to coordinate on-site AVEA ventilator correction in a timely, effective manner. The FDA and other regulatory authorities have been notified.
In the news release, CareFusion said the recall does not require the facility to return affected AVEA ventilators. Until the on-site repair can be arranged, 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, the facility should immediately remove the ventilator from service, and provide alternate ventilation to the patient. The facility should contact CareFusion Technical Support to report the issue.
Customers can contact CareFusion by phone at 1.888.562.6018 or email the support center at SupportCenter@carefusion.com between the hours of 6:30 a.m. and 5:00 p.m. PDT.
Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.