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.
[36883406]
While prepping the pt, anesthesiologist expressed concerns about increasing etco2 levels, possible malignant hyperthermia. Malignant hyperthermia cart immediately brought in. Etco2 went from 30% to 50%. No temperature elevation noted. Foley cath draining yellow urine. Pt given 8 vials of dantrolene. Istat labs drawn sicu called report, cooling blanket. Per intensivist: except for hypercarbia, pt has no tachycardia, no muscle rigidity and no hyperthermia, and the cpk levels were normal. Suspicion for malignant hyperthermia is very less at this point. Believed upon further investigation, this may have been caused by the sodasorb filter turning to violet, then back to white without color change being noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059548 |
| MDR Report Key | 5384780 |
| Date Received | 2016-01-18 |
| Date of Report | 2016-01-18 |
| Date of Event | 2015-11-12 |
| 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 |