inforMED
MalfunctionCBL

AMSORB 3# BAGS

Received Jan 19, 2001 · Event occurred Dec 1, 2000

Report 1411365-2001-00002 · MDR key 313479

Device

Generic name

Carbon Dioxide Absorbent

Model number

NA

Catalog number

12343

Lot number

UNK

Product problems

  • Output, high
  • Other (for use when an appropriate device code cannot be identified)

Patient

UNKNOWN

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

REPORT 2 OF 4 RECEIVED OF INADEQUATE CARBON DIOXIDE ABSORPTION DURING ANESTHESIA. THE REPORTER STATES THAT THE END-TIDAL CO2 LEVEL INCREASED TO 50-55% AND THE INSPIRED CO2 LEVEL INCREASED TO 25%. THE HOSES AND VALVES WERE VERIFIED TO BE FUNCTIONING PROPERLY ON THE ANESTHESIA CIRCUIT. THE FRESH GAS FLOW WAS THEN INCREASED FROM 1L/MIN TO 5L/MIN. THE CO2 LEVELS THEN NORMALIZED. THE REPORTER STATES THAT THE PT HAD A "STORMY EMERGENCY WITH DELIRIUM." THE REPORTER IS UNSURE IF THAT RELATES TO THE CO2 EXPERIENCE OR THE PT'S MEDICAL HISTORY. THE PT'S VITAL SIGNS REMAINED STABLE AND THE O2 SATURATION REMAINED 98-100%. AT FIRST APPEARANCE THE GRANULES LOOK WHITE. THE UPPER CANISTER WAS DISMANTLED AND THERE WAS A BLUE COLOR CORE, SURROUNDED BY WHITE. THE LOWER CANISTER HAD NO COLOR CHANGE. THE COLOR INDICATOR IS ADDED DURING MANUFACTURE AND HAS A SENSITIVE PH FACTOR THAT CAUSES THE GRANULES TO CHANGE COLOR AS THEY NEAR EXHAUSTION. ALTHOUGH REQUESTED, THE PT'S SEX AND AGE WERE UNKNOWN TO THE REPORTER. THERE WAS NO REPORT OF ADVERSE PT SEQUELAE. ADD'L PT INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.