inforMED
MalfunctionCBL

AMSORB 1K CARTRIDGES

Received Dec 19, 2000 · Event occurred Nov 1, 2000

Report 1411365-2000-00004 · MDR key 309579

Device

Generic name

Carbon Dioxide Absorbent

Model number

NA

Catalog number

12344

Lot number

67-009-DD

Product problems

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

Patient

UNKNOWN

  • Manual ventilation required

Narrative

Description of Event or Problem

REPORT RECEIVED OF INADEQUATE CARBON DIOXIDE ABSORPTION DURING ANESTHESIA. THE CUSTOMER STATES, "THAT AFTER THE AMSORB HAS BEEN USED FOR SEVERAL SURGERIES, THEY START TO GET INCREASED CO2 LEVELS. THEY SHAKE THE CANISTERS AND GET ABOUT ANOTHER FIVE MINUTES OUT OF THE AMSORB, BEFORE THE CO2 LEVEL BEGINS TO RISE AGAIN." WHEN THIS OCCURS THEY CHANGE OUT THE AMSORB FOR BARALYME. THE CUSTOMER REPORTS THAT THE AMSORB IS "CHANNELING AND CHANGES COLOR IN THE CENTER FROM TOP TO BOTTOM." THE COLOR INDICATOR IS ADDED DURING MANUFACTURE AND HAS A SENSITIVE PH FACTOR THAT CAUSES THE GRANULES TO CHANGE COLOR AS THEY NEAR EXHAUSTION. ALL OF THE PTS ARE MECHANICALLY VENTILATED WITH FLOW RATES AT 1-2L/MIN. THE CUSTOMERS USES "STANDARD" ANESHTESIA MACHINES. NO ADVERSE PT EFFECT HAS BEEN REPORTED. ADD'L INFO WAS REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.