STELLANT DUAL CT INJECTOR
Report
- Report Number
- 2520313-2023-00028
- Event Type
- Injury
- Date Received
- October 31, 2023
- Date of Event
- October 3, 2023
- Report Date
- September 23, 2024
- Manufacturer
- BAYER MEDICAL CARE INC.
- Product Code
- DXT
- UDI-DI
- 00616258020860
- PMA / PMN Number
- K082905
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) HAS BEEN SCHEDULED. THE DISPOSABLE KIT IN USE DURING THE EVENT IS UNAVAILABLE AND DISPOSABLE INFORMATION IS UNKNOWN. THE SITE CONTINUES TO USE THE MEDRAD® STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) WAS COMPLETED ON NOVEMBER 21, 2023 WHICH CONFIRMED THE INJECTOR WAS PERFORMING WITHIN BAYER SPECIFICATIONS. THE DISPOSABLE KIT IN USE DURING THE EVENT IS UNAVAILABLE AND DISPOSABLE INFORMATION IS UNKNOWN. AN OFFER OF ADDITIONAL CLINICAL APPLICATIONS TRAINING HAS BEEN MADE TO THE CUSTOMER AND WAS DECLINED. THE SITE CONTINUES TO USE THE MEDRAD® STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. THE MEDRAD® STELLANT CT INJECTION SYSTEM OPERATION MANUAL CAUTIONS THE USER AS FOLLOWS: WARNING: AIR EMBOLIZATION CAN CAUSE DEATH OR SERIOUS INJURY TO THE PATIENT. DO NOT CONNECT A PATIENT TO THE INJECTOR UNTIL ALL TRAPPED AIR HAS BEEN CLEARED FROM THE SYRINGE AND FLUID PATH. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
A SYSTEM SERVICE CHECK OF THE MEDRAD® STELLANT CT INJECTION SYSTEM (SERIAL NUMBER (B)(6)) HAS BEEN SCHEDULED AND WE ARE AWAITING THE RESULTS. THE DISPOSABLE KIT IN USE DURING THE EVENT IS UNAVAILABLE AND DISPOSABLE INFORMATION IS UNKNOWN. THE SITE CONTINUES TO USE THE MEDRAD® STELLANT CT INJECTION SYSTEM AFTER THE REPORTED EVENT WITH NO FURTHER ISSUES REPORTED. THIS INVESTIGATION REMAINS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.
UDI RELATED DATA QUALITY UPDATES ONLY. CORRECTION: FOR UDI DATA DISCREPANCY/MISMATCH ON PREVIOUSLY SUBMITTED MDR AND TO ENSURE THE DEVICE IDENTIFICATION DATA IS IN ALIGNMENT WITH GUDID.
BAYER MEDICAL CARE INC. WAS INFORMED OF AN ALLEGED AIR INJECTION WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR OBSERVATION AND HAS SINCE RECOVERED.
BAYER MEDICAL CARE INC. WAS INFORMED OF AN ALLEGED AIR INJECTION WHILE A PATIENT WAS CONNECTED TO A MEDRAD® STELLANT CT INJECTION SYSTEM (SN (B)(6)). ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE EXAMINATION, THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED FOR OBSERVATION AND HAS SINCE RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2032703 | STELLANT DUAL CT INJECTOR | CT INJECTION SYSTEM | DXT | BAYER MEDICAL CARE INC. | 85937286 | 00616258020860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Male | Other |