AMSORB 1K CARTRIDGES

Description of Event or Problem

REORT RECEIVED OF INADEQUATE CARBON DIOXIDE ABSORPTION DURING ANESTHESIA. CUSTOMER STATES THERE HAVE BEEN THREE OCCURRENCES WHERE THE CARBON DIOXIDE WAVEFORM HAD ELEVATED DURING THE USE OF AMSORB. THE AMSORB IS PLACED IN BOTH OF THE CARBON DIOXIDE ABSORBER CANISTERS ON THE ANESTHESIA MACHINE. THE ANESTHESIOLOGIST OBSERVED CHANGES ON THE END TIDAL CARBON DIOXIDE MONITOR INDICATING RISING CARBON DIOXIDE LEVELS. THE INCREASE IN THE WAVEFORM HAS OCCURRED WITHIN 15 MINUTES OF THE BEGINNING OF THE SURGERY CASE. THE AMSORB IS THEN REPLACED WITH SODA-LIME AND THE CARBON DIOXIDE WAVEFORM RETURNS TO NORMAL. CUSTOMER REPORTS THAT WHEN THE AMSORB CANISTERS WERE REMOVED, THEY NOTICED THAT THE GRANULES ON THE TOP HAD CHANGED COLOR OR THE COLOR CHANGE HAD OCCURRED JUST THROUGH THE CENTER FROM TOP TO BOTTOM. THE COLOR INDICATOR IS ADDED DURING MFR AND HAS A SENSITIVE PH FACTOR THAT CAUSES THE GRANULE TO CHANGE COLOR AS THE GRANULES NEAR EXHAUSTION. THE ANESTHESIOLOGIST REPORTED, "IT APPEARED THAT 5% TO 10% OF THE AMSORB HAD BEEN USED." IN ALL THREE INSTANCES, A DIFFERENT ANESTHESIA MACHINE WAS USED. THERE WAS NO REPORT OF ADVERSE PT EVENT.