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The QMN Weekly Bulletin

CareFusion Provides Update on Avea Ventilator Recall

June 12, 2015

BD’s CareFusion subsidiary issued an update on its recall of the Avea ventilator to provide clarification on certain units of the product. The device is intended for continuous breathing support in infants through adults.

CareFusion initiated the Class I voluntary recall after reports of a potential malfunction of Avea’s 5 psi pressure transducer.

According to the reports, the ventilators may develop a failure mode over time, which causes their extended high peak or circuit occlusion audio and visual alarms to go off, opens the safety valve and stops ventilation. This could cause oxygen levels in the blood to drop or carbon dioxide levels to rise dangerously.

As of May 27, no patient injuries or deaths had been reported, the company said.

The worldwide recall affects ventilators sold from July 1, 2011, to March 15, 2015.

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