MEDISORB

Description of Event or Problem

THERE ARE GRANULES GETTING PAST THE FILTER AND GOING INSIDE THE ANESTHESIA MACHINES AND CAUSING DELAYS IN PATIENT CARE. ANESTHESIA MACHINES ARE MALFUNCTIONING DUE TO THE DUST FROM THE SODASORB ENTERING THE BREATHING SYSTEM. DELAYED PROCEDURE AND ANESTHESIA MACHINES REPAIRED.

Additional Manufacturer Narrative

ALL INFORMATION REASONABLY KNOWN AS OF 03 JUNE 2025 HAS BEEN INCLUDED IN THIS 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 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 CAUSED SERIOUS INJURY.

Description of Event or Problem

THERE ARE GRANULES GETTING PAST THE FILTER AND GOING INSIDE THE ANESTHESIA MACHINES AND CAUSING DELAYS IN PATIENT CARE. ANESTHESIA MACHINES ARE MALFUNCTIONING DUE TO THE DUST FROM THE SODASORB ENTERING THE BREATHING SYSTEM. DELAYED PROCEDURE AND ANESTHESIA MACHINES REPAIRED.

Additional Manufacturer Narrative

ALL INFORMATION REASONABLY KNOWN AS OF 03 JUNE 2025 HAS BEEN INCLUDED IN THIS 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 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 CAUSED SERIOUS INJURY THE COMPLAINT OF "THERE ARE GRANULES GETTING PAST THE FILTER AND GOING INSIDE THE ANESTHESIA MACHINES AND CAUSING DELAYS IN PATIENT CARE. ANESTHESIA MACHINES ARE MALFUNCTIONING DUE TO THE DUST FROM THE SODASORB ENTERING THE BREATHING SYSTEM. DELAYED PROCEDURE AND ANESTHESIA MACHINES REPAIRED. " REGARDING PART M1173310 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE SINCE 18NOV2024 MANUFACTURING RELEASE PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.