MEDISORB

Description of Event or Problem

DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY. CANISTER WAS REPLACED AND COULD NOT VENTILATE OR OXYGENATE PATIENT. CANISTER REMOVED AND FOUND TO BE CRACKED, USED CONTAINER. COULD NOT VENTILATE OR OXYGENATE PATIENT. THIS WAS THE SECOND INCIDENT DISCOVERED WITH THE SAME ISSUE DURING INVESTIGATION FOR (B)(4), MDR REPORT (B)(4). DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER (LATER CANISTER1) AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY. CANISTER1 WAS REPLACED (WITH CANISTER2) AND COULD NOT VENTILATE OR OXYGENATE PATIENT. CANISTER2 REMOVED AND FOUND TO BE CRACKED, USED CONTAINER(CANISTER1) THEN REPLACED UNTIL ANESTHESIA TECH COULD BRING REPLACEMENT CANISTER (CANISTER3). THIS COMPLAINT HANDLES CLAIMS RELATED TO CANISTER1. FOR CANISTER2, SEE (B)(4)

Additional Manufacturer Narrative

H6: 4MEDISORB - ABSORBER. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER (LATER CANISTER1) AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY." REGARDING PART M1173310 MEDISORB ORIGINAL WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF TOO LONG USE. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. THERE HAVE BEEN 6 OTHER COMPLAINTS REGARDING THE OTHER PARTS CONTAINING SAME SODALIME AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

Additional Manufacturer Narrative

H6: 4MEDISORB - ABSORBER. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03 JAN 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT - (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

Description of Event or Problem

DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY. CANISTER WAS REPLACED AND COULD NOT VENTILATE OR OXYGENATE PATIENT. CANISTER REMOVED AND FOUND TO BE CRACKED, USED CONTAINER. COULD NOT VENTILATE OR OXYGENATE PATIENT. THIS WAS THE SECOND INCIDENT DISCOVERED WITH THE SAME ISSUE DURING INVESTIGATION FOR COMPLAINT -(B)(4), MDR REPORT 3010838917-2025-0001. DURING THORACIC SURGERY CASE, ANESTHESIOLOGIST ATTEMPTED TO REPLACE USED SODASORB CONTAINER (LATER CANISTER1) AS PATIENT WAS STARTING TO HAVE INCREASED INSPIRATION OF CARBON DIOXIDE WHICH COULD BE HARMFUL DURING THE SURGERY. CANISTER1 WAS REPLACED (WITH CANISTER2) AND COULD NOT VENTILATE OR OXYGENATE PATIENT. CANISTER2 REMOVED AND FOUND TO BE CRACKED, USED CONTAINER(CANISTER1) THEN REPLACED UNTIL ANESTHESIA TECH COULD BRING REPLACEMENT CANISTER(CANISTER3). THIS COMPLAINT HANDLES CLAIMS RELATED TO CANISTER1. FOR CANISTER2, SEE COMPLAINT-(B)(4).