MalfunctionCBL
SODASORB
Received Jan 10, 2018 · Event occurred Dec 14, 2017
Report 7178130 · MDR key 7178130
Device
Product problems
- Inadequate Instructions for Healthcare Professional
- Device Operates Differently Than Expected
Patient
Not reported
- Respiratory Distress
- Respiratory Distress
Narrative
Description of Event or Problem
THE DESIGN OF THE PRODUCT ALLOWS FOR THE PRODUCT TO BE PLACED IN THE ANESTHESIA MACHINE (MINDRAY) UPSIDE DOWN AND ONCE THE ABSORBENT IS EXHAUSTED AND WET THE CANISTER CANNOT BE RELEASED FROM THE HOLDER. THE UPPER CIRCUMFERENCE OF THE CANISTER IS MARGINALLY LARGER THAN THE BOTTOM; HOWEVER THERE IS NO NOTATION ON THE SUPPLY TO INDICATE HOW THE CANISTER SHOULD BE PLACED IN THE HOLDER I.E. THIS END UP, ETC. ONE PATIENT'S ETC02 REACHED 70 AND REQUIRED MANUAL VENTILATION WHILE THE CANISTER WAS REMOVED FROM THE HOLDER.