CARBOLIME * 55-01-0025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-08 for CARBOLIME * 55-01-0025 manufactured by Allied Healthcare Products, Inc..

Event Text Entries

[3045462] Upon intubation of patient, it was discovered that the anesthesia machine had a leak and would not hold pressure. The anesthesia was unable to ventilate patient and deliver anesthetic gases. Oxygen tubing was obtained immediately from bed in hallway and patient was manually bagged through endotracheal tube. An intravenous (iv) connection was obtained so that sedating agents could be delivered to the intubated patient and the clinical engineering department (ce) was notified immediately. Ce diagnosed the problem in 10-15 minutes. The site of the leak was a carbolime canister and rotating them fixed the leak. They were able to continue the case. However, this is the 3rd time in 5 days we have had problems. Upon closer inspection, the carbolime insert is disfigured and do not fit in the canisters as they should. This caused the air leak. The inner canister appeared to be slightly to large and it took a good deal of force to get it to seat properly. We received two more cases with lot# c26312, and they still do not work. Also lot# c24912a would not seat properly. Eventually we were able to find cannisters within lot# c26312 that did fit like they were supposed to. ======================manufacturer response for co2 absorbent, carbolime (per site reporter). ======================after multiple attempts on nov 1 i was finally able to reach the manufacturer representative. She stated that they were aware of the fit problem. I asked them for communication regarding what lot numbers were safe to use and received no additional communication from them. We eventually had to find a good lot number through trial and error.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2854124
MDR Report Key2854124
Date Received2012-11-08
Date of Report2012-11-08
Date of Event2012-10-23
Report Date2012-11-08
Date Reported to FDA2012-11-08
Date Added to Maude2012-12-03
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 NameCARBOLIME
Generic NameABSORBENT, CARBON-DIOXIDE
Product CodeCBL
Date Received2012-11-08
Model Number*
Catalog Number55-01-0025
Lot NumberC24912A
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerALLIED HEALTHCARE PRODUCTS, INC.
Manufacturer Address1720 SUBLETTE AVENUE ST LOUIS MO 63110 US 63110

Device Sequence Number: 2

Brand NameCARBOLIME
Generic NameABSORBENT, CARBON-DIOXIDE
Product CodeCBL
Date Received2012-11-08
Model Number*
Catalog Number55-01-0025
Lot NumberC26312
ID Number*
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerALLIED HEALTHCARE PRODUCTS, INC.
Manufacturer Address1720 SUBLETTE AVENUE ST LOUIS MO 63110 US 63110


Patients

Patient NumberTreatmentOutcomeDate
10 2012-11-08

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