MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	85937286
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	01/30/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
A bayer service injector system checkout, as well as a request for the return of the disposables and/or lot numbers used in the reported incident, has been made and is awaiting the customer response.In the event that additional information is obtained, 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.
Event or Problem Description
The customer reported that an alleged air injection and subsequent patient death occurred while a medrad® stellant ct injection system (sn (b)(6)) was in use.A request for additional information, including an autopsy report and/or cause of death report, has been made.However, the hospital indicated that a police investigation was underway and therefore, limited information is available at this time.
Additional Manufacturer Narrative
On february 28, 2025, bayer medical care was informed that the police have sealed the room at the hospital.Therefore, an investigation of equipment and/or disposables cannot be performed at this time.In the event that additional information is obtained, 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.
Event or Problem Description
The customer reported that an alleged air injection and subsequent patient death occurred while a medrad® stellant ct injection system (sn (b)(6)) was in use.A request for additional information, including an autopsy report and/or cause of death report, has been made.However, the hospital indicated that a police investigation was underway and therefore, limited information is available at this time.
Event or Problem Description
The customer reported that an alleged air injection and subsequent patient death occurred while a medrad® stellant ct injection system (sn (b)(6)) was in use.A request for additional information, including an autopsy report and/or cause of death report, has been made.However, the hospital indicated that a police investigation was underway and therefore, limited information is available at this time.
Additional Manufacturer Narrative
On july 17, 2025, bayer medical care was informed that the medrad® stellant ct injection system (sn (b)(6)) has not been released for evaluation.Multiple documented attempts have been made to gain specific information related to the reported event, including disposable information; however, those attempts have been unsuccessful.Therefore, an investigation of the equipment and/or disposables cannot be carried out.Our investigation concluded that there is insufficient evidence of product malfunction or the failure of the device to meet specification.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 21297498
• Report Number: 2520313-2025-00002
• Device Sequence Number: 7871186
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)190909
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 85937286
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/28/2025; 07/17/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/04/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown