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 2010-08-05 for SODASORB M1173312 * manufactured by Ge Healthcare, Vital Signs, Inc.

Event Text Entries

[1574337] Our hospital had used a product from ge named "medisorb" for a long period of time, with no issues or concerns. This product is a co2 absorbent used in all of our anesthesia machines. In early july it was noted that our facility started receiving a different product from ge. Initially we returned the product thinking it was an error in ordering. We again received and returned the different product. Upon questioning, ge stated they had discontinued making medisorb and that they had sent a letter which our materials management department did not receive. We have multiple concerns with the replacement product: 1. The lid to the canisters containing the sodasorb are not grooved in any way, they just sit on the base which allows the lid to "pop off" easily letting the toxic pellets into the operating rooms. 2. The top edge of the base portion of the canister has cracked in several instances which allows pressure leaks and excessive amount of dust in the or's. In the past 2 weeks our anesthesia machines have had to be repaired/cleaned twice due to excessive dust. The dust causes machine leaks, gets everywhere, on the machine seals and in the past it has even made it through the machine to the patient circuit. 3. The replacement product is not labeled with a product name. The canister just states prepackaged cartridge, original, disposable. There also appear to be 2 lot numbers on the packaging with neither of them being located where the canister says "lot". One is printed in small letters running horizontally on canister... The other is around the upper lip of canister. 4. It is felt by anesthesiology staff that the sodasorb heats to a much higher temperature than the original medisorb and appears to need changing with higher frequency. It is also taking staff a large amount of time troubleshooting issues, safely removing excess dust out of the product without compacting the granules in an effort to maintain the utmost co2 absorption. 5. We have been told other facilities have started voicing similar complaints and ge has been in contact with the manufacturer and it has been suggested that a movement for change may be starting. Our facility will not be using this product. We feel it is unsafe to our patients, our staff and our equipment. Both canisters are from same lot number. We are now trialing an alternate product from a different vendor. ======================manufacturer response for co2 absorbent canister ======================multiple emails and meetings with product rep.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1803659
MDR Report Key1803659
Date Received2010-08-05
Date of Report2010-08-05
Date of Event2010-07-09
Report Date2010-08-05
Date Reported to FDA2010-08-05
Date Added to Maude2010-08-17
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 Details

Brand NameSODASORB
Generic NameABSORBENT, CARBON-DIOXIDE
Product CodeCBL
Date Received2010-08-05
Model NumberM1173312
Catalog Number*
Lot NumberC201-P133-08
ID Number*
OperatorOTHER
Device AvailabilityY
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE, VITAL SIGNS, INC
Manufacturer Address3000 N. GRANDVIEW BLVD MAILSTOP: W450 WAUKESHA WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.