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Mindray A3 and A5 Anesthesia Delivery System: Class I Recall - Gasket Leak

Friday, November 30, 2012

AUDIENCE: Risk Manager, Anesthesiology

ISSUE: FDA notified health professionals of a Class I Recall of the Mindray A3 and A5 Anesthesia Delivery System. The affected devices may have a gasket leak which could cause an interruption of or inadequate patient anesthesia and ventilation, temporary or permanent patient injury, or death. The gasket leak could also cause injury to bystanders and operating room personnel due to exposure from leaking anesthesia gases.

The company has identified the cause of the leak as a small step in the gasket surface which may interfere with the full seating of the gasket within the canister. The leak may be identified during the Automatic Circuit Leak and Compliance Test performed at start up and during the Manual Leak Test recommended before each use.

The devices were manufactured between May 2011 to March 2012 and distributed between May 31, 2011 to July 15, 2012.

BACKGROUND: The A3 and A5 anesthesia delivery systems are used to administer continuous or intermittent general anesthesia gases and maintain a patient’s breathing during surgery. These devices are used for both pediatric and adult patients.

Mindray first informed customers about this recall in a letter, dated August 8, 2012. The letter identified the problem with the device and possible adverse effects on patients.

RECOMMENDATION: Facilities should consider having backup equipment to maintain patient ventilation in the event of device failure due to this issue. Mindray is in the process of correcting the leak issue by replacing canister gaskets on affected devices. According to the company, as of November 14, 2012, approximately 70% of units affected by this action were corrected.

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 a link to the Recall Noticef, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm330249.htm

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