MAUDE MDR 1075905

MDR report key
1075905
Report number
1075905
Event key
0
Event type
3
Date of event
2008-06-25
Date received
2008-07-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SODASORBCO2 ABSORBENTSMITH MEDICAL ASD INCCBL**CWO2-P115-21 AND CWO1-P115-19N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-07-0201. R

Event Narratives#

D

Patient 1

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.