Description of Event or Problem · 1
REBREATHING CIRCUIT LEAD FROM INSPIRATORY SIDE OF CO-2 ABSORBING CANNISTER TO A HEATED HUMIDIFIER, THEN TO THE PATIENT. FROM THE PATIENT, THE EXPIRATORY LIMB ATTACHED TO AN AIR FILTER LOCATED ON THE EXPIRATORY PORT OF THE CO-2 ABSORBER. HEATED HUMIDIFIER WAS ON AT 35- 37 DEGREES C DURING CASE. NO PARTICULATE H-2-O WAS EVER NOTED IN THE EXPIRATORY OBSTRUCTION WHICH IN TIME WAS SHOWN AS A BLOCKAGE TO AIR FLOW BY THE AIR FILTER. WE ASSUME THIS BLOCKAGE WAS DUE TO MOISTURE. WE COULD NOT IDENTIFY HOW PARTICULATE H-2-0 COULD HAVE COME IN CONTACT WITH THIS FILTERDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: OTHER, OTHER, BACTERIAL FILTER, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.