SODALIME
Received May 18, 1994
Report 1912755-1994-00004 · MDR key 15140
Device
Product problems
- False Negative Result
Patient
*
Narrative
Description of Event or Problem
THE DEVICE IS PLACED IN THE CARBON DIOXIDE SCAVENGING CANISTER. AS THE ABSORBED CARBON DIOXIDE, THE COLOR OF THE GRANULES SHOULD CHANGE FROM WHITE TO VIOLET. CLINICALLY UNACCEPTABLE LEVELS OF CARBON DIOXIDE WERE SEEN IN PTS WITHOUT A COLOR CHANGE OCCURRING. WHEN THE GRANULES WERE FINALLY CHANGED, "CLUMPING" OF THE GRANULES WAS NOTICED.