SODASORB
Received Jul 2, 2008 · Event occurred Jun 25, 2008
Report 1075905 · MDR key 1075905
Device
Generic name
Co2 Absorbent
Manufacturer
Smith Medical Asd IncModel number
*Catalog number
*
Lot number
CWO2-P115-21 AND CWO1-P115-19
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
7 *
- ST Segment Elevation
Narrative
Description of Event or Problem
WHILE PERFORMING AN ASD/VSD REPAIR ON A SEVERAL WK OLD BABY, WE NOTED ST SEGMENT ELEVATION WITHOUT CHANGES IN HEMODYNAMICS. THIS HAPPENED ABOUT 10 MINS AFTER DESFLURANE WAS INITIATED. WE CHECKED A CO-OX BLOOD GAS AND THE CARBOXYHEMOGLOBIN LEVEL WAS 5.2% (SIGNIFICANTLY ELEVATED). OF NOTE, THE CHEST WAS OPENED AND WE LOOKED DIRECTLY AT THE CORONARY ARTERIES AND THERE WAS NO EVIDENCE OF ANY COMPRESSION OR PERFUSION ABNORMALITIES. THE PHYSICIAN SUSPECTED THAT THE ELEVATED CARBOXYHEMOGLOBIN LEVELS WERE THE RESULT OF A BAD BATCH OF CO2 ABSORBENT. IT HAS BEEN DOCUMENTED IN THE LITERATURE THAT CARBON MONOXIDE IS PRODUCED IF VOLATILE ANESTHETICS (I.E. DESFLURANE, ENFLURANE, HALOTHANE, ISOFLURANE AND SEVOFLURANE) COME IN CONTACT WITH A DRIED OR DESICCATED CO2 ABSORBENTS, SUCH AS SODA LIME. ELEVATED CARBOXYHEMOGLOBIN LEVELS IN THE PATIENT CAN RESULT. THIS PARTICULAR PATIENT'S CONDITION STABILIZED AFTER REMOVAL FROM THE ANESTHESIA UNIT. SINCE THE CO2 ABSORBER HAD BEEN CORRECTLY CHANGED THE DAY PRIOR (BOTH CANISTERS), WE SUSPECT THAT A BAD BATCH OF ABSORBENT WAS RECEIVED. IMMEDIATELY FOLLOWING THE INCIDENT THE CO2 ABSORBENT SUPPLIER WAS CONTACTED. THE CANISTERS IN QUESTION WERE SEQUESTERED, AND WERE SENT TO AN OUTSIDE TEST LAB. AREAS OF INVESTIGATION WILL BE LOT NUMBERS, CLIMATE CONTROL STORAGE AND THE REVIEW OF OTHER HOSPITALS WITH SIMILAR INCIDENTS. THE ANESTHESIA MACHINE HAD UNDERGONE PREVENTIVE MAINTENANCE 3 MONTHS PRIOR, AND WILL BE TESTED AGAIN BY BIOMEDICAL ENGINEERING TO VERIFY CORRECT OPERATION.