DRAGERSORB
Received Oct 26, 2007 · Event occurred Oct 19, 2007
Report 935449 · MDR key 935449
Device
Generic name
Soda Lime Canister
Manufacturer
Drager Medical Ag And Co. KgaaModel number
*Catalog number
*
Lot number
ARXN-F002
Product problems
- Air Leak
- Alarm, audible
- Disassembly
- Foreign material
- Leak/Splash
- Seal, incorrect
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DURING A ROUTINE PROCEDURE (USING GENERAL ANESTHETIC) WITH THE PATIENT BREATHING SPONTANEOUSLY THROUGH AN LMA (LARYNGEAL MASK AIRWAY), THE ANESTHESIA MACHINE ALARMED: LOW FRESH GAS FLOW, NEGATIVE PRESSURE WHILE IN THE PRESSURE SUPPORT MODE. RETURN TO SPONTANEOUS MODE CAUSED THE ALARM TO STOP. AFTER THE PROCEDURE IT WAS FOUND THAT THE SODA LIME CANISTER HAD CREATED A SMALL NEGATIVE PRESSURE LEAK WHICH STARTED THE ALARM. SODA LIME PARTICLES WERE NOTED TO BE ESCAPING THE SEALED PORTION OF THE CANISTER AND GETTING INTO THE BREATHING CIRCUIT AND INTO THE MACHINE. THE SEAL INSIDE THE CANISTER WAS INSERTED SIDEWAYS WITHIN THE CANISTER, ALLOWING THE SODA LIME PARTICLES OUT OF THE SEALED PORTION. THE MACHINE HAD PASSED ALL SAFETY/LEAK CHECKS THAT MORNING.