CareFusion Issues Update on Recall of AVEA VentilatorsJun 1, 2015
Last week, CareFusion issued an update on a voluntary global recall initiated on April 21, 2015 to address an issue with certain AVEA ventilators.
The AVEA ventilator is used to provide continuous breathing support for neonatal through adult patients in hospitals and health care facilities. The recall was undertaken 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 the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve, and stops ventilating, according to a company news release.
If the malfunction occurs, the patient will need alternate ventilation support to reduce the potential of hypoxemia (low oxygen) or hypercapnia (increased carbon dioxide in the blood).
The ventilators included in the global recall were manufactured and distributed between July 1, 2011 and March 15, 2015. CareFusion learned of the problem through customer reports identifying Extended High Ppeak or Circuit Occlusion alarms. The CareFusion website provides a full list of affected model and serial numbers and also information about how to locate the ventilator’s serial number. The ventilators were distributed in more than 90 countries around the world.
The Food and Drug Administration (FDA) classified this as a Class I recall, which is the agency’s most serious recall category. A Class I recall is 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 work 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. CareFusion said its Recall Support Center is contacting customers via telephone to coordinate on-site repair of AVEA ventilators in a timely, effective manner. The company has notified the FDA and other regulatory authorities of the recall.
In the news release, CareFusion said the recall does not require hospitals and health care facilities to return the ventilators. Repairs will be done on site. Until the 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 and this cannot be cleared by turning the ventilator off and back on again, the facility should immediately remove that ventilator from service, and provide alternate breathing support. 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.