FDA Recalls – November 2013

FDA RECALLS - November


Recall – Did Not Pass High Voltage Test Portion Of Final Production Test

AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine

ISSUE: Drager issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Investigations determined that on some power supply units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained. In extreme cases, the influence of mechanical forces, such as movement of the device, for example, may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected. To date, there have been no reported injuries or reported failures due to this issue.

BACKGROUND: This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013 and May 2013 and distributed in the United States between March 2013 and June 2013. Affected devices were distributed nationally (see firm press release for information on affected serial numbers by model).

RECOMMENDATION: If users of the Fabius anesthesia machines experience such a failure of the automatic ventilation function, they should switch over to the manual ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob, and start manual ventilation. Additional details concerning switching to manual ventilation in case of a fault are provided in the Instructions for Use in the Fault-Cause-Remedy and Ventilator Fail Safe sections. Hospitals are urged to notify their personnel accordingly.

For questions regarding the operation and/or servicing of affected Drager anesthesia machines in the United States, call DragerService Technical Support at 800-543-5047 (press 4 at the prompt) between the hours of 8 a.m. to 8 p.m. EST Monday through Friday, or contact Drager by email at info.usa@draeger.com.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/ report.htm.

Download the form or call 800332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178.



CareFusion issued the following update regarding its previously announced voluntary recall of Avea ventilators.

The company initiated the voluntary recall on Sept. 3, 2013. The FDA has classified this action as a Class I recall. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

CareFusion announced a voluntary recall of AVEA ventilators regarding barometric pressure sensor compensation when using the neonatal wye hot wire flow sensor. AVEA ventilators may experience an underreporting of tidal volume if used in conjunction with the neonatal hotwire flow sensor. The patient may receive a higher than expected tidal volume. The error is due to lack of barometric pressure sensor compensation.

While all AVEA ventilators fall under this voluntary recall, hospitals in locations at high elevations (higher than 5,000 feet above sea level) that are using the AVEA ventilator in the neonatal patient care setting are at greatest risk of this error. The level of underreporting between displayed flow and actual flow increases proportionately with altitude. CareFusion has received five complaints from a facility that was operating in the neonatal patient care settings and was located higher than 5,000 feet above sea level. No injuries have been directly attributed to this issue.

The Food and Drug Administration has been notified of this recall.

Instructions to customers: CareFusion does not require the return of the devices.

CareFusion advises its customers in locations higher than 5,000 feet above sea level using the AVEA ventilator in neonatal patient care settings with a wye hot wire flow sensor to take one of the following actions:

If using the AVEA Comprehensive ventilator, continue the use of the ventilator using the VarFlex single-patient use sensor (CareFusion part number 5000040038), and discontinue use of the neonatal hotwire flow sensor until the software correction has been installed.

If using the AVEA Standard ventilator, discontinue use in neonatal patient care settings and contact CareFusion customer support.

If a hospital is located below 5,000 feet above sea level no action is necessary at this time.

Customer inquiries related to this action should be addressed to the CareFusion Customer Support Center at 888-562-6018 between the hours of 7 a.m. to 4:30 p.m. PDT, Monday through Friday.

Customers may also contact the company by email at SupportCenter@carefusion.com and the support center will follow up with customers.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA at www.fda. gov/Safety/MedWatch/HowtoReport/default.htm (form available to fax or mail), or call FDA at 800-FDA-1088.