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

Model Number	85577026
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care was notified of an alleged air injection that had occurred during a ct scan while the patient was connected to a medrad® stellant flex ct injection system (serial number (b)(6)).A 32-year old male patient from the emergency department was undergoing a ct with contrast of the abdomen and pelvis for a chief complaint of left lower quadrant (llq) pain.During the procedure, approximately 90cc of air was visualized on the displayed images.The patient returned to the emergency department and was subsequently transferred to another facility to undergo hyperbaric oxygen therapy.The patient is reported to be in good condition.
Additional Manufacturer Narrative
A system service check of the stellant ct injector (serial number (b)(6)) was completed on september 21, 2023, which confirmed that the injector was operating within bayer specifications.The stellant flex disposable set that was in use during the procedure was discarded by the site; therefore, it is not available for evaluation.The customer was unable to provide the lot number of the disposables; therefore, testing of retained samples was not possible.The customer declined the offer of additional clinical applications training.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.
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: 17896204
• Report Number: 2520313-2023-00024
• Device Sequence Number: 15205235
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219(11)210414
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Administrator/Supervisor
• Type of Report: Initial,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: 85577026
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male