CareFusion 211, Inc., AVEA Ventilators, All Models

Recall Class: Class I

Date Recall Initiated: September 5, 2013

Product: AVEA Ventilators, All Models

This recall affects settings for infants under 5 ½ pounds (2500 grams). The adult and pediatric patient settings are not affected by this recall.

Use: The AVEA ventilator is a continuous ventilator intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. These ventilators are used in hospitals and other health care institutions.

Recalling Firm:
CareFusion 211, Inc.
22745 Savi Ranch Parkway
Yorba Linda, California 92887

Reason for Recall:
AVEA ventilators may experience an under-reporting of tidal volume if used in conjunction with the neonatal wye hotwire flow sensor, CareFusion part number 16465. The patient may receive a higher than expected tidal volume. Changes in ambient air pressure, such as atmospheric pressure above 5,000 Feet ASL may trigger the device malfunction. As a result of the device malfunction, the use of AVEAs ventilator at altitudes greater than 5000 feet ASL may cause serious adverse health consequences, including death.

Public Contact:

FDA District: Los Angeles District Office

FDA Comments:
On September 5, 2013, CareFusion sent its customer an URGENT PRODUCT RECALL letter, dated September 3, 2013. The letter informed customers of recalled product name, description, and serial numbers enclosed as a list unique to each customer. The customer letter also stated the problem and affected devices, issue, potential risk, actions to be taken by CareFusion, action to be taken by the customer and distributor, and contact Information.

ACTION TO BE TAKEN BY CAREFUSION
CareFusion has initiated a project to develop a new version of software that will resolve this issue. Once this software is available to download customers will receive a notification letter.

ACTION TO BE TAKEN BY THE CUSTOMER

• CareFusion does not require the return of your devices.
• If the location of your AVEA ventilator(s) is above 5,000 feet (1, 524 meters), and you are using the AVEA in the neonatal patient setting, customers are asked to take one of the following actions.
  • AVEA Comprehensive: Continue the use of your AVEA Comprehensive ventilator with the use of a VarFiex™ single patient use flow sensor, CareFusion part number 50000-40038 (10 pack).
  • AVEA Standard: Discontinue the use of your AVEA Standard ventilator in the neonatal patient setting.
• If the location of your hospital is located at altitude above 5,000 feet (1 ,524 meters) a CareFusion customer support representative will contact you to arrange for a suitable alternative if necessary.
• If the location of your hospital is below 5,000 feet (1 ,524 meters), or the ventilator is exclusively used in the adult and/or pediatric patient setting, no action is necessary.
• Please promptly return the enclosed response card to expedite the correction process and acknowledge receipt of this notification.

ACTION TO BE TAKEN BY THE DISTRIBUTOR:

• CareFusion does not require the return of your device(s).
• Please notify your competent authority or regulating agency and submit the FSCA report and the FSN (customer letter) to them, as per your local country regulations.
• Customers and distributor partners are asked to initiate one of the following actions:
  • If the location of your AVEA ventilator(s) is above 1,524 meters ASL and you are using the AVEA in the neonatal patient setting, customers are asked to take one of the following actions.
    • AVEA Comprehensive: Continue the use of your AVEA Comprehensive ventilator with the use of a VarFiex™ single patient use flow sensor, CareFusion part number 50000-40038 (10 pack).
    • AVEA Standard: Discontinue the use of your AVEA Standard ventilator in the neonatal patient setting.
  • If the location of your hospital is below 1,524 meters, or the ventilator is exclusively used in the adult and/or pediatric patient setting, no action is necessary.
• Return the enclosed response card within 5 days from date of receipt to expedite the correction process and acknowledge receipt of this notification.
• Translate enclosed letter if required per local regulatory requirements.
• Provide the customer letter and collect response cards.
• Return response cards immediately to CareFusion at the address provided.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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