MalfunctionCBL
SODA LIME CARTRIDGE
Received Aug 21, 1995
Report 1912755-1995-00003 · MDR key 26185
Device
Generic name
Co2 Absorbent
Manufacturer
Graber-roggModel number
0-120040-00Catalog number
NA
Lot number
948065G94
Product problems
- False Negative Result
Patient
NA
Narrative
Description of Event or Problem
THE HOSP REPORTED THAT IN TWO DIFFERENT SITUATIONS, THE SODALIME DID NOT CHANGE COLOR SIGNIFICANTLY AND THE CO2 LEVELS WERE HIGH FOR THE PT. REPORTEDLY, THE SODALIME HAS BEEN USED IN THE MACHINE LONGER THAN NORMAL BECAUSE OF LOW VOLUME OF SURGERIES IN THE OPERATING ROOM. THE HOSP HAS BEEN REMINDED OF THE INFO CONTAINED IN THE PRODUCT LABELING REGARDING REGENERATION AND MOISTURE EFFECTS ON SODALIME. THE HOSP INDICATED THEY WILL CLOSELY MONITOR THE SODALIME IN THE FUTURE.