inforMED
MalfunctionCBL

SODA LIME CARTRIDGE

Received Aug 21, 1995

Report 1912755-1995-00003 · MDR key 26185

Device

Generic name

Co2 Absorbent

Manufacturer

Graber-rogg

Model number

0-120040-00

Catalog 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.