AMSORB 1K CARTRIDGES

Description of Event or Problem

VOLUNTARY MEDWATCH FORM RECEIVED FROM CUSTOMER WHICH STATES, "PROBLEM WITH PACKAGING. THE CARTRIDGES DON'T FIT TIGHTLY ENOUGH TO KEEP PT'S EXHALED AIR FROM ESCAPING TO OUTSIDE OF CARTRIDGE. PT RISK IS THAT THEY MAY REBREATHE EXPIRED CO2 CAUSING INSPIRED CO2 TO RISE SIGNIFICANTLY. HAVE SEEN ANYWHERE FROM 29MMHG TO 32MMHG INSPIRED CO2 LEVELS. THE CANISTERS HAVE BEEN TAKEN OUT OF SERVICE. THEY WERE BEING USED IN A TRAIL. PT WAS NOT HARMED." ADD'L INFO RECEIVED FROM CUSTOMER THAT "AIR FLOW IS GOING AROUND THE CARTRDIGE." THIS WAS EXPERIENCED ON MECHANICALLY AND SPONTANEOUS VENTILATED PTS. THE FLOW RATE WAS LESS THAN 2L/MIN. THE INSPIRED CO2 WOULD INCREASE TO 30MMHG. THE TOTAL FLOW WOULD BE INCREASED TO 12L/MIN. AND THEN THE INSPIRED CO2 WOULD DECREASE TO 10 OR LESS. NEITHER THE UPPER OR LOWER CARTRIDGES HAD CHANGED COLOR. THE COLOR INDICATOR IS ADDED DURING MANUFACTURE AND HAS A SENSITIVE PH FACTOR THAT CAUSES THE GRANULES TO CHANGE COLOR AS THEY NEAR EXHAUSTION. THE GRANULES WERE TAKEN OUT OF THE CARTRIDGE AND PUT DIRECTLY INTO THE CO2 ABSORBER CANISTER. ONCE THE GRANULES WERE PUT INTO THE CANISTER, THEY ABSORBED AS EXPECTED. ALTHOUGH REQUESTED, IT WAS UNKNOWN TO THE REPORTER THE PT AGES, SEX OR DIAGNOSIS. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.