MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-11 for CARDIOGEN 82 manufactured by Bracco Injeneering S. A..
[133484063]
The reporter, a pharmacist, states that 8 different pts received higher doses than intended due to a malfunction of the cardiogen 82 device on three separate days. On (b)(6) 2018, (2 pts), (b)(6) 2018 (2 pts), and (b)(6) 2018 (4 pts).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083078 |
| MDR Report Key | 8248386 |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-15 |
| Date Added to Maude | 2019-01-15 |
| 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 | PHARMACIST |
| 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 | CARDIOGEN 82 |
| Generic Name | INJECTOR, CONTRAST MEDIUM, AUTOMATIC |
| Product Code | IZQ |
| Date Received | 2019-01-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING S. A. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-11 |