MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for STELLANT DUAL CT INJECTOR 60726807 SCT W/CERTEGRA manufactured by Bayer Medical Care Inc..
[188648598]
A system service check of the stellant ct injector, serial number (b)(4), was completed on january 31, 2020 which confirmed that the injector was operating within bayer specifications. There was no evidence of equipment malfunction. The stellant disposable set that was in use during the procedure was discarded by the site and unavailable for evaluation. The customer was unable to provide the lot number of the disposables used during the incident; therefore, testing of retained samples was not possible. The offer of additional clinical applications training has been made to the customer and we are awaiting their response. The site continues to use the stellant ct injection system after the reported event with no further issues reported.
Patient Sequence No: 1, Text Type: N, H10
[188648599]
Bayer medical care was notified of an extravasation that occurred during an enhanced ct scan while a patient was connected to a stellant ct injection system. The customer reported that approximately 220ml of fluid extravasated (120 ml contrast and 100ml saline) an icepack was applied to the affected extremity and the patient was re-evaluated the following day by a surgeon who determined that they should continue to apply ice as needed. No further medical intervention was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520313-2020-00006 |
| MDR Report Key | 9739549 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2017-08-22 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DIANE ECKERT |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal | 15051 |
| Manufacturer Phone | 7249408677 |
| Manufacturer G1 | BAYER MEDICAL CARE INC. |
| Manufacturer Street | 1 BAYER DRIVE |
| Manufacturer City | INDIANOLA PA 15051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STELLANT DUAL CT INJECTOR |
| Generic Name | CT INJECTION SYSTEM |
| Product Code | DXT |
| Date Received | 2020-02-21 |
| Model Number | 60726807 |
| Catalog Number | SCT W/CERTEGRA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other; 2. Required No Informationntervention | 2020-02-21 |