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

Model Number	60726807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer medical care completed a service checkout of the stellant ct injection system on (b)(6) 2022, which found the system to be performing to specifications.The site continues to use the medrad® stellant ct injection system after the completed checkout with no further issues reported.The disposables that were in use during the procedure were requested for evaluation by bayer product analysis; however, they were discarded by the customer and are therefore unavailable for testing.In addition, the customer was unable to provide lot numbers for the disposables in use at the time of the incident.As a result, testing of retained samples is unable to be performed at this time.The customer declined an offer for additional applications training at this time.The following excerpts are contained in the medrad® stellant ct injection system operation manual: expel all trapped air from the syringe(s), connectors, tubing, and catheter before connecting the system to the patient.Before connecting the tubing to the patient, visually inspect the syringe and tubing to confirm that all air is purged.To minimize air embolization risks, ensure that one operator is designated the responsibility of filling the syringe(s).Do not change operators during the procedure.If an operator change must occur, ensure that the new operator verifies that the fluid path is purged of air.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 received information that a 73-year-old male patient who was undergoing a cta scan of the thorax with contrast suffered an alleged air injection while connected to a medrad® stellant ct injection system.The customer reported that approximately 8-10 mls of alleged air was visualized by the radiologist in the patient's main pulmonary artery while reviewing the images.The patient was placed in trendelenburg, left lateral decubitus position, and then administered high flow oxygen.The patient was admitted to the intensive care unit for monitoring.No additional treatment was reported.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 16121804
• Report Number: 2520313-2023-00002
• Device Sequence Number: 15592910
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 01/09/2023

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: 60726807
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLANT DISPOSABLES
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male