MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-02-20 for SPECTRIS MRI INJECTION SYSTEM SDV200 * manufactured by Medrad, Inc..
[367189]
An iv line was connected to the pt and the injector was primed to start kvo [keep vein open]. To keep iv line open, start was mashed [pushed] on the injector. The button may have been stuck because contrast was injected instead of kvo. Doctors had to reschedule study until the next day. Before using the injector again, both syringes were loaded with water and ran through set up and injection again. System ok'd. Device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 512240 |
| MDR Report Key | 512240 |
| Date Received | 2004-02-20 |
| Date of Report | 2003-11-01 |
| Date of Event | 2003-11-01 |
| Date Added to Maude | 2004-02-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | SPECTRIS MRI INJECTION SYSTEM |
| Generic Name | MRI INJECTOR |
| Product Code | DQF |
| Date Received | 2004-02-20 |
| Model Number | SDV200 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501237 |
| Manufacturer | MEDRAD, INC. |
| Manufacturer Address | ONE MEDRAD DR INDIANOLA PA 15051 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-20 |