MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-17 for AMSORB 1K CARTRIDGES 12344 manufactured by Armstrong Medical Ltd..
[190774]
Report rec'd of inadequate carbon dioxide absorption during anesthesia. The customer states, "there have been four cases in which the inspired carbon dioxide levels were elevated up to greater than 20. " the average flow rates used are 1-2 liters. The time into surgery when the co2 levels started increasing were variable. The amsorb was changed with new absorbent when the inspired co2 levels begin increasing. With the change of the absorbent the co2 levels would normalize. The customer reports that the used amsorb appeared white around the outside, with the top layer and the center appearing purple down to and including the top of the lower canister. The color indicator is added during mfr and has a sensitive ph factor that causes the granule to change color as the grannules near exhaustion. All of the pts were mechanically ventilated on drager3 machines. No adverse pt effect has been reported. Add'l info was requested, but no further info available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1411365-2001-00007 |
| MDR Report Key | 334222 |
| Date Received | 2001-05-17 |
| Date of Report | 2001-04-20 |
| Date of Event | 2000-12-01 |
| Date Facility Aware | 2001-04-20 |
| Report Date | 2001-05-17 |
| Date Reported to FDA | 2001-05-17 |
| Date Reported to Mfgr | 2001-05-11 |
| Date Added to Maude | 2001-05-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSORB 1K CARTRIDGES |
| Generic Name | CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2001-05-17 |
| Model Number | NA |
| Catalog Number | 12344 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323570 |
| Manufacturer | ARMSTRONG MEDICAL LTD. |
| Manufacturer Address | WATTSTOWN BUSINESS PARK NEWBRIDGE RD. COLERAINE EI |
| Baseline Brand Name | AMSORB 1K CARTRIDGES |
| Baseline Generic Name | CARBON DIOXIDE ABSORBENT |
| Baseline Model No | NA |
| Baseline Catalog No | 12344 |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-17 |