MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-08 for CARBOLIME 55-01-0006 manufactured by Allied Healthcare Products, Inc..
[670818]
It was reported that the carbolime had been a single canister absorber for 1 week. They had done about 10 hours of surgery using sevoflorane at a flow of 1 lpm. The carbolime was a dark color and smelled like something burnt when removed.
Patient Sequence No: 1, Text Type: D, B5
[7975997]
A single canister of carbolime is generally good for about 5. 5 hours of surgery. Therefore, at 10 hours of surgery, it was used almost twice as long as it should have been. Carbolime needs to be changed based on the color change as it is being used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1924066-2007-00006 |
| MDR Report Key | 863481 |
| Report Source | 05 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-05-26 |
| Date Mfgr Received | 2007-05-26 |
| Date Added to Maude | 2008-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3147712400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBOLIME |
| Generic Name | CO2 ABSORBENT |
| Product Code | CBL |
| Date Received | 2007-06-08 |
| Model Number | 55-01-0006 |
| Lot Number | 40617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 958592 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | ST. LOUIS MO 63110 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-08 |