FDA Issues Class I Recall for AVEA Ventilators

Roxanne Nelson

Disclosures

December 23, 2011

December 23, 2011 — The US Food and Drug Administration (FDA) has notified healthcare professionals of a class I recall of CareFusion AVEA ventilators.

According to the manufacturer, a potential risk has been identified with certain AVEA ventilators that were manufactured between March 1, 2009, and June 30, 2011, along with ventilators that were serviced with affected parts during this same period. The affected ventilators may develop a failure mode over a period of time, where the ventilator activates a false extended high peak (peak cycling respiratory pressure) alarm, opens the safety valve (by design), and stops ventilating.

The activation of the high peak alarm initiates audio and visual alarms in addition to opening the safety valve. Breaths are not delivered while the alarm is activated, and instead, the opening of the safety and exhalation valves allows the patient to breathe from room air. The patient is not subjected to elevated airway pressures. If an alternative form of ventilation is not provided by healthcare professionals, patients may thus suffer life-threatening injury or death.

The AVEA ventilator is used in hospitals and other healthcare facilities and is intended for continuous breathing support for the care of neonatal through adult patients.

Previous Notifications

CareFusion first notified customers with an urgent recall notice on September 15, 2011, and with a follow-up letter on October 4, 2011. The recall notice informed customers that their Recall Support Center would be contacting them to arrange for onsite remediation of the affected devices.

In an update to their previously announced ventilator recall, CareFusion has now informed customers that the FDA is designating this action as a Class I recall. This is the most serious type of recall and involves situations in which there is a reasonable probability that continued use of a product can result in serious adverse health consequences or death.

In their latest release, CareFusion notes that there is no change to the remediation plans that were previously announced by the company and that they are actively remediating the hardware on affected units. The company also states that they have determined the root cause for the issue and are committed to updating each device in a timely manner with minimal disruption to customers.

To date, CareFusion has received 94 reports of incidents involving malfunction of the ventilator. No deaths or injuries were reported.

More information about the recall is available at the CareFusion Web site.

Customer inquiries related to this action should be addressed to CareFusion Technical Support at 1-800-231-2466.

To report adverse reactions or quality problems experienced with use of these products, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....