MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-18 for SODASORB CARBON-DIOXIDE ABSORBENT manufactured by Grace Discovery Sciences.
[36906063]
Pt to the operating room for cholecystitis. Towards the end of the case the anesthesiologist communicated a mild increase in etco2. Troubleshooting was completed, became concerned for malignant hyperthermia r/t elevated co2. Pt received dantrolene and was stable. All appropriate steps to treat and prevent worsening condition. Pt to the icu for monitoring. Upon further investigation felt to most likely be caused by the sodasorb filter not being noted if it did turn violet and then turning back to white.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059549 |
| MDR Report Key | 5384782 |
| Date Received | 2016-01-18 |
| Date of Report | 2016-01-18 |
| Date of Event | 2015-10-01 |
| Date Added to Maude | 2016-01-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SODASORB CARBON-DIOXIDE ABSORBENT |
| Generic Name | SODASORB CARBON DIOXIDE ABSORBENT |
| Product Code | CBL |
| Date Received | 2016-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GRACE DISCOVERY SCIENCES |
| Manufacturer Address | COLUMBIA MD 21044 US 21044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-01-18 |