SODASORB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-02 for SODASORB * manufactured by Smith Medical Asd Inc.

Event Text Entries

[881447] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1075905
MDR Report Key1075905
Date Received2008-07-02
Date of Report2008-07-02
Date of Event2008-06-25
Report Date2008-07-02
Date Reported to FDA2008-07-02
Date Added to Maude2008-07-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSODASORB
Generic NameCO2 ABSORBENT
Product CodeCBL
Date Received2008-07-02
Model Number*
Catalog Number*
Lot NumberCWO2-P115-21 AND CWO1-P115-19
ID Number*
OperatorPHYSICIAN
Device Availability*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1042629
ManufacturerSMITH MEDICAL ASD INC
Manufacturer Address160 WEYMOUTH ST ROCKLAND MA 02370 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-07-02

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