MalfunctionCBL
CARBOLIME
Received Jun 8, 2007 · Event occurred May 26, 2007
Report 1924066-2007-00006 · MDR key 863481
Device
Generic name
Co2 Absorbent
Manufacturer
Allied Healthcare Products, Inc.Model number
55-01-0006Lot number
40617
Product problems
- Material Discolored
- Device Emits Odor
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CARBOLIME HAD BEEN A SINGLE CANISTER ABSORBER FOR 1 WEEK. THEY HAD DONE ABOUT 10 HOURS OF SURGERY USING SEVOFLORANE AT A FLOW OF 1 LPM. THE CARBOLIME WAS A DARK COLOR AND SMELLED LIKE SOMETHING BURNT WHEN REMOVED.
Additional Manufacturer Narrative
A SINGLE CANISTER OF CARBOLIME IS GENERALLY GOOD FOR ABOUT 5.5 HOURS OF SURGERY. THEREFORE, AT 10 HOURS OF SURGERY, IT WAS USED ALMOST TWICE AS LONG AS IT SHOULD HAVE BEEN. CARBOLIME NEEDS TO BE CHANGED BASED ON THE COLOR CHANGE AS IT IS BEING USED.