October 16, 2013
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue
AUDIENCE: Risk Manager, Anesthesiology, Health Professional
ISSUE: GE Healthcare has initiated a voluntary field corrective for the Avance, Aisys and Avance CS2 anesthesia delivery systems with 8.00 (Avance and Aisys) or 10.00 (Avance CS2) software due to a potential safety issue. Clinicians may continue to use their Avance, Aisys and Avance CS2 anesthesia delivery system, but should be aware that a unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume when using the Pressure Control Ventilation – Volume Guarantee (PCV-VG) mode. All safety over-pressure controls and alarms will continue to function properly, however, over delivery of tidal volume this may result in alterations to blood flow within the thorax that, under extreme circumstances, may result in gradual reductions in blood pressure. To date, no patient injuries have been reported with regards to this issue.
BACKGROUND: The affected units were manufactured from February 2011 through July 2013. The unique sequence of inputs includes transitioning from mechanical PCV-VG mode to manual ventilation, changing the set tidal volume (while in manual mode), and then returning to mechanical PCV-VG mode.
RECOMMENDATION: To avoid this situation, when using PCV-VG mode, clinicians are advised not to adjust the ventilator tidal volume while in a manual ventilation mode. At any time during the use of the device, should an over delivery of tidal volume occur while in PCV-VG mode, transitioning to a different ventilation mode will resolve the issue. GE Healthcare has begun notifying customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and provides instructions to mitigate the issue. GE Healthcare is following up with all customers and will correct all affected systems at no cost to customers.
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 form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Firm Press Release at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm371038.htm.