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

Model Number	85631829
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check report of the medrad® stellant flex injection system (serial number (b)(6) was completed on november 3, 2023 which confirmed that the injector was operating within bayer specifications.Multiple documented attempts have been made to gain specific information related to the reported event, including disposables involved; however, these attempts have been unsuccessful.In the event that additional information is obtained, a follow-up report will be submitted.The medrad® stellant flex 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.
Event or Problem Description
Bayer medical care inc.Was informed that a patient suffered an air injection while connected to a medrad® stellant flex ct injection system sn (b)(6).The technologist noticed an absence of contrast on the displayed images and the patient began coughing following the injection.The emergency department physician noticed air on the displayed images.The patient was subsequently transferred to another hospital for an elevated level of care.The current status of the patient is unknown.
Additional Manufacturer Narrative
A system service check report of the medrad® stellant flex injection system (serial number (b)(6)) was completed on november 3, 2023 which confirmed that the injector was operating within bayer specifications.Disposables involved during the event were discarded and disposable information was not provided.The offer of additional applications training was accepted and provided by the bayer clinical performance team.The medrad® stellant flex 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.
Event or Problem Description
On november 21, 2023 bayer medical care inc.Received the following additional information from the customer: a 61-year-old male suffered an air injection while connected to a medrad® stellant flex ct injection system (sn (b)(6)).Following the injection, the technologist noticed an absence of contrast on the study images.The emergency department physician visualized an estimated 60-100 ml of air on the displayed images.While under observation in the emergency department, the patient was given benadryl, placed in left lateral recumbent trendelenburg position, and had their oxygen level increased from 2 to 6 liters via nasal cannula.The patient was subsequently transferred to a cardiac unit for monitoring and was discharged to home two days later.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.

• 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: 18192239
• Report Number: 2520313-2023-00031
• Device Sequence Number: 12581649
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792(11)090901
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192370
• 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,Followup
• Report Date (Section B): 09/23/2024

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: 85631829
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2023
• Supplement Date Received by Manufacturer: 11/28/2023; Not provided; Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/11/2023; 09/23/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• 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: Other
• Patient Age: 61 YR
• Patient Sex: Male