SODASORB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-20 for SODASORB manufactured by .

Event Text Entries

[1008327] Pt with underlying heart disease came to the operating room for operative repair. Upon induction of anesthesia developed cardiovascular collapse requiring cpr and emergent initiation of extracorporeal membrane oxygenation (ecmo) as a life saving intervention. Within a few days, she was weaned from ecmo and survived. A number of factors about the evident suggested carbon monoxide toxicity: this was the first case, using a machine that had been idle for 4 days. The pt had a profound junctional bradycardia rhythm within five minutes of exposure to volatile gas (sevoflurane). This was completely unresponsive to resuscitative agents such as epinephrine or atropine. The blood was noted to be "cherry red" during cpr and upon cannulation for ecmo with pao2s in the 200-300 range (highly unusual during cardiovascular collapse). The carboxyhemoglobin level in the icu (after 4 hours of 100% oxygen and being diluted by the ecmo pump volume) was 2. 1% (elevated). The only organ injury sustained was evidence of basal ganglia ischemia. Although non-specific, this is also highly consistent with carbon monoxide exposure. She suffered no other organ injury or ill effects from this event. Her brain injury resulted in significant neurologic impairment. Because i was suspicious that carbon monoxide may be produced during routine anesthetics, i prospectively evaluated carboxyhemoglobin levels in five children less than 1 year of age undergoing mask induction with sevoflurane. We measured cohb levels 15-30 min after induction. These are the results that suggest carbon monoxide exposure during routine anesthetics: a male for ventricular septal defect repair, cohb level 5%. A male with tricuspid atresia for blalock-taussig shunt, cohb level 6%. A female with tetralogy of fallot for catheterization, cohb level 4%. A female for gastric tube, cohb 11%. At the end of the case on 100% oxygen 30 min later, the level was 1%. A male for gastric tube, cohb 7%. It is known that carbon monoxide can be produced when volatile anesthetic agents contact co2 absorbent. However, it has not been fully evaluated in children. Certainly, the smallest children are at the greatest risk and exposure could potentially result in higher levels of carboxyhemoglobin. The literature suggests that even low levels of carbon monoxide can be deleterious to the developing brain. This needs to be evaluated rapidly on a multi-institution basis to assess the safety and/or potential danger of co exposure during routine anesthetics in children.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009852
MDR Report Key1304303
Date Received2008-08-20
Date of Report2008-08-20
Date of Event2008-05-19
Date Added to Maude2009-02-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSODASORB
Generic NameNONE
Product CodeCBL
Date Received2008-08-20
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2008-08-20

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