November 30, 2012 — Mindray Medical International is voluntarily recalling the A3 and A5 Anesthesia Delivery Systems due to a potential gasket leak. The U.S. Food and Drug Administration (FDA) has also issued a Class 1 recall because the defect could potentially cause severe injury or death to the patient or caregivers in the operating room. No injuries have been reported in association with the defect.
The problem was identified when customers noticed a “step” in the gasket while performing routine tests of the machine before surgery. The defect could potentially cause a patient to be under-anesthetized before surgery. Because surgery patients are also given a paralyzing drug, they may feel pain and hear conversations but be unable to communicate with their physician.
The FDA has also warned that serious injuries could occur, including:
“…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.”
As a precautionary measure, the FDA recommends that facilities with the device should have some sort of back-up ventilation system in case the gasket leak causes failure of the device during surgery.
The recalled A3 and A5 devices were manufactured beginning in May 2011 and distributed until July 15, 2012. Mindray has already sent notifications to the customers who purchased the device and more than 70% of the anesthesia systems have been fixed.
The FDA reserves Class 1 recalls for products that have a “good chance” of causing severe injury or death to a patient. Class 1 recalls are also the most serious recall.
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