SODASORB M1173312 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-30 for SODASORB M1173312 * manufactured by Ge Healthcare, Vital Signs, Inc.

Event Text Entries

[19247142] Elderly female patient taken to or for total knee procedure. It was reported by the anesthesia tech that the datex ohmeda aestiva-5 anesthesia machine had encountered problems. It was noted the bellows on the machine were not rising appropriately. Back up machine was obtained and switched out with original machine with no further reported issues with either the 2nd machine or the patient. Anesthesia tech reports upon troubleshooting the issue it was noted the machine had an excessive amount of dust originating from the co2 absorbent canister. We have reported this problem with this product previously but this is the first time it has directly affected patient/procedure. Our hospital had determined we would not be using this product as soon as the replacement product we had found (amsorb plus) arrived at our hospital. Our facility has now just learned the supplier of sodasorb has now determined they will not be ordering from this particular vendor anymore and will be returning to their original product (medisorb) which had been discontinued. No injury to patient, just a delay in procedure with having to switch to an alternate machine and an impact of time as it took our anesthesia staff time to clean large amount of dust out of machine and run machine through its paces before feeling secure enough to return it to service. ======================manufacturer response for prepackaged co2 absorbent cartridge, sodasorb======================manufacturer is aware our hospital has been very unhappy with the sodasorb product. We had used medisorb for quite some time with no issues and then suddenly sodsasorb just started being delivered in its place. We expressed concern and started evaluating other products from other manufacturers. We have now learned the sodasorb product will now be discontinued and ge will be returning to the original medisorb product.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1825089
MDR Report Key1825089
Date Received2010-08-30
Date of Report2010-08-30
Date of Event2010-08-16
Report Date2010-08-30
Date Reported to FDA2010-08-30
Date Added to Maude2010-09-03
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameSODASORB
Generic NamePREPACKAGED CO2 ABSORBENT CARTRIDGE
Product CodeCBL
Date Received2010-08-30
Model NumberM1173312
Catalog Number*
Lot NumberC201-P133-08
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE, VITAL SIGNS, INC
Manufacturer Address3000 N. GRANDVIEW BLVD WAUKESHA WI 53188 US 53188

Device Sequence Number: 2

Brand NameAESTIVA
Generic NameGAS-MACHINE, ANESTHESIA
Product CodeBSZ
Date Received2010-08-30
Model Number5
Catalog Number*
Lot Number*
ID Number*
Device Sequence No2
Device Event Key0
ManufacturerGE HEALTHCARE DATEX OHMEDA
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-30

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