MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for STELLANT CT INJECTOR 3037301 STELLANT D manufactured by Bayer Medical Care, Inc..
[57714392]
Patient Sequence No: 1, Text Type: N, H10
[57714393]
I hooked up patient to the power injector to pre-flush her iv with saline, but as i was watching the iv site for infiltration,i realized the injector was pushing the contrast instead of the saline. I double checked the protocol that i locked for the injector to load and it was correct. The patient received 50 cc visipaque (visi) prior to scan. I called the radiologist and she didn't want me to reload to give the patient another full dose for the scan. Biomed was called, injector was inspected and sensors were found to not be reading correctly and adjustments were made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6036236 |
| MDR Report Key | 6036236 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-05-23 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2016-10-18 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLANT CT INJECTOR |
| Generic Name | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
| Product Code | IZQ |
| Date Received | 2016-10-18 |
| Model Number | 3037301 |
| Catalog Number | STELLANT D |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER MEDICAL CARE, INC. |
| Manufacturer Address | 1 BAYER DRIVE INDIANOLA PA 15051 US 15051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-18 |