CARBOLIME CARBON DIOXIDE ABSORBENT

Additional Manufacturer Narrative

UNITS INVOLVED HAVE NOT BEEN RETURNED FOR EVALUATION. TYPE OF ANESTHESIA MACHINE/CARBON DIOXIDE ABSORBER INVOLVED WAS NOT STATED. THE FDA 1993 ANESTHESIA APPARATUS CHECKOUT LIST STATES "PERFORM LEAK CHECK OF MACHINE LOW PRESSURE SYSTEM." THESE CHECKS SHOULD BE DONE BEFORE USE. INSTRUCTIONS THAT ARE PROVIDED WITH ANESTHESIA MACHINE AND ABSORBERS GENERALLY STATE PERFORMED A LEAK TEST BEFORE USING THE MACHINE. THE CANISTERS GENERALLY SLIDE FREELY INTO THE ABSORBER. THEREFORE, IT SHOULD HAVE BEEN APPARENT THAT THE CANISTERS DID NOT FIT PROPERLY IN THE ABSORBER AT THE TIME OF INSTALLATION AND BEFORE USE ON THE PT.

Description of Event or Problem

IT WAS REPORTED THAT UPON INTUBATION OF PT, IT WAS DISCOVERED THAT THE ANESTHESIA MACHINE HAD A LEAK AND WOULD NOT HOLD PRESSURE. THE ANESTHESIA WAS UNABLE TO VENTILATE PT AND DELIVER ANESTHETIC GASES. OXYGEN TUBING WAS OBTAINED IMMEDIATELY FROM A BED IN THE HALLWAY AND PT WAS MANUALLY BAGGED THROUGH ENDOTRACHEAL TUBE. AN INTRAVENOUS (IV) CONNECTION WAS OBTAINED SO THAT SEDATING AGENTS COULD BE DELIVERED TO THE INTUBATED PT AND CLINICAL ENGINEERING DEPARTMENT (CE) WAS NOTIFIED IMMEDIATELY. CE DIAGNOSED THE PROBLEM IN 10 - 15 MINUTES. THE SITE OF THE LEAK WAS A CARBOLIME CANISTER AND ROTATING THEM FIXED THE LEAK. THEY WERE ABLE TO CONTINUE THE CASE. HOWEVER, THIS IS THE 3RD TIME IN 5 DAYS WE HAVE HAD PROBLEMS. UPON CLOSER INSPECTION, THE CARBOLIME INSERT IS DISFIGURED AND DO NOT FIT IN THE CANISTER AS THEY SHOULD. THIS CAUSE THE AIR LEAK. THE INNER CANISTER APPEARED TO BE SLIGHTLY LARGER AND IT TOOK A GOOD DEAL OF FORCE TO GET IT TO SEAT PROPERLY. WE RECEIVED TWO MORE CASES WITH LOT #C26312, AND THEY STILL DO NOT WORK. ALSO LOT# C24912A WOULD NOT SEAT PROPERLY. EVENTUALLY WE WERE ABLE TO FIND CANISTERS WITH LOT # C26312 THAT DID FIT LIKE THEY WERE SUPPOSE TO .