TOPIC: AMSORB PLUS PREFILLED G-CAN 1.0L by Armstrong Medical Limited: Class I Recall - Due to Reduced Gas Flow to Patients During Anesthesia
AUDIENCE: Patient, Health Professional, Risk Manager, Anesthesiology
ISSUE: Armstrong Medical Limited is recalling this product due to reports that some AMSORB PLUS PREFILLED G-CAN 1.0L canisters have difficulties with gas flow that may cause a reduced flow of air to the patient. The difficulties in flow may cause a failure in the pre-use or “CHECK-OUT” test on the anesthesia machine. It may also occur when a patient is already under anesthesia if an affected canister is attached to the anesthesia machine while a patient is already under anesthesia.
If the flow issue is not addressed, this may prevent the ventilator from providing enough breathing assistance to the patient (hypoventilation), leading to a build-up of carbon dioxide in the patient’s body and causing negative health effects.
There have been no deaths or injuries reported for this recall.
BACKGROUND: AMSORB PLUS is a chemical substance used in anesthesia machines to absorb carbon dioxide (CO2) the patient breathes out while under anesthesia.
RECOMMENDATIONS: On August 5, 2021, Armstrong Medical Limited sent an urgent medical device correction letter to customers. The letter requested that nursing and medical staff (caregivers) working in anesthesia and critical care:
• Review the list of devices that are potentially impacted by the recall.
• Complete and return the customer response form to Armstrong Medical Limited or the distributor the device was received from to receive replacement units.
• If users temporarily keep their stock of potentially affected devices, the company asks that they make sure a revised pre-use test is completed as a supplement to the existing “CHECK-OUT” test procedure, to make sure that the ventilator functions correctly.
The company also advises:
• Canisters should be replaced intraoperatively if unexpected, elevated gas flow resistance is observed or expected during clinical use, with or without associated anesthesia machine alarms.
• During a procedure, fresh gas flow rate should be increased above the required minute ventilation volume until the end of the anesthesia procedure if an installed canister no longer adequately absorbs CO2 (due to absorbent exhaustion). The canister should then be replaced after the procedure is ended.
Health 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.
•Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
Read the full recall.