AMSORB 1K CARTRIDGES
Received Nov 6, 2000 · Event occurred Oct 1, 2000
Report 1411365-2000-00002 · MDR key 304368
Device
Generic name
Carbon Dioxide Absorbent
Manufacturer
Armstrong Medical Ltd.Model number
NACatalog number
12344
Lot number
67-010-6E
Product problems
- False Device Output
Patient
UNKNOWN
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
REPORT RECEIVED OF INADEQUATE CARBON DIOXIDE ABSORPTION DURING ANESTHESIA. THE CUSTOMER STATES THERE HAVE BEEN REPEATABLE INCIDENTS OF CARBON DIOXIDE LEVELS INCREASING DURING THE USE OF AMSORB. AMSORB IS PLACED IN BOTH OF THE CARBON DIOXIDE CANISTERS OF THE ANESTHESIA MACHINE. THE ANESTHESIOLOGISTS OBSERVED CHANGES ON THE END TIDAL CARBON DIOXIDE MONITOR INDICATING RISING CO2 LEVELS. THE LEVELS WOULD RISE OVER A PERIOD OF TIME, OVER SEVERAL SURGERY CASES. THE AMSORB IS THEN REPLACED WITH A SODA-LIME PRODUCT AND THE CARBON DIOXIDE LEVEL RETURNS TO NORMAL. THE INCIDENTS OCCURRED WITH FIVE DIFFERENT ANESTHESIA MACHINES. THERE WAS NO REPORT OF ADVERSE PT EVENT.