MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-02 for CARBOLIME CARBON DIOXIDE ABSORBENT 55-01-0025 manufactured by Allied Healthcare Products, Inc..
[21046077]
It was reported that upon intubation of pt, it was discovered that the anesthesia machine had a leak and would not hold pressure. The anesthesia was unable to ventilate pt and deliver anesthetic gases. Oxygen tubing was obtained immediately from a bed in the hallway and pt was manually bagged through endotracheal tube. An intravenous (iv) connection was obtained so that sedating agents could be delivered to the intubated pt and 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 canister as they should. This cause the air leak. The inner canister appeared to be slightly larger 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 canisters with lot # c26312 that did fit like they were suppose to.
Patient Sequence No: 1, Text Type: D, B5
[21305670]
Units involved have not been returned for evaluation. Type of anesthesia machine/carbon dioxide absorber involved was not stated. The fda 1993 anesthesia apparatus checkout list states "perform leak check of machine low pressure system. " these checks should be done before use. Instructions that are provided with anesthesia machine and absorbers generally state performed a leak test before using the machine. The canisters generally slide freely into the absorber. Therefore, it should have been apparent that the canisters did not fit properly in the absorber at the time of installation and before use on the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1924066-2012-00010 |
| MDR Report Key | 2947551 |
| Report Source | 05,06 |
| Date Received | 2013-01-02 |
| Date of Report | 2013-01-02 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-12-11 |
| Device Manufacturer Date | 2012-09-10 |
| Date Added to Maude | 2013-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 46 NEW STREET |
| Manufacturer City | STUYVESANT FALLS NY 12174 |
| Manufacturer Country | US |
| Manufacturer Postal | 12174 |
| Manufacturer Phone | 3142681661 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBOLIME CARBON DIOXIDE ABSORBENT |
| Generic Name | CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2013-01-02 |
| Model Number | 55-01-0025 |
| Catalog Number | 55-01-0025 |
| Lot Number | C26312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | STUYVESANT FALLS NY 12174 US 12174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-02 |