CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically co

FDA device recall Z-1609-2015 · posted 2015-05-26 · Terminated

Recall details

Recalling firm

Carefusion 211 Inc dba Carefusion

Reason for recall

A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

Action taken

A customer letter dated 4/21/15 will be sent to all customers who received the AVEA Ventilator, all models, to inform them that CareFusion has identified a potential risk associated with AVEA Ventilator caused by a malfunction of a pressure transducer. The malfunctioning pressure transducer is detected and by design ceases ventilation and opens the safety valve to atmosphere allowing spontaneous breathing of patients capable of doing so. The non-breathing patient would need to be manually ventilated. The letter informs the customers of the issues, the potential risk, and the actions to be taken. Customers are instructed to contact CareFusion Recall Support Center at (888) 562-6018, (858) 617-5300, or email supportcenter@carefusion.com for recall related questions. Customers are instructed to contact CareFusion Technical Support/Customer Advocacy at (800) 231-2466, (714) 283-2228, or email support.vent.us@carefusion.com for Product Technical Support Adverse Event Reporting. CareFusion posted a press release on their website on 5/27/15 and it was sent to PRNewswire. The press release 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 press release provide the problems and the actions to be taken. The press also list the countries that are affected by the recall.

Root cause

Process control

Status

Terminated

Product code

CBK

Quantity affected

15,905 units total (5,670 units in US)

Distribution

Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda,

Date initiated

2015-04-03

Date posted

2015-05-26

Date terminated

2018-07-23

Location

Yorba Linda, CA

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