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

Model Number	85937286
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer medical care received information that a 70-year-old female patient who was undergoing a ct scan of the chest with contrast suffered an alleged air injection while connected to a medrad® stellant ct injection system.The customer reported that approximately 40-50 mls of alleged air was visualized by the radiologist in the patient's heart when reviewing the images.No patient complications were reported.The patient was admitted for observation overnight and then discharged the next day.No additional treatment was necessary.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (sn (b)(4)) was completed by bayer service on september 15, 2022.The system was found to perform to specifications and has been in use daily following the reported occurrence.The customer was unable to provide the specific disposables used in the reported occurrence for evaluation.In addition, lot numbers were not recorded, therefore testing of retained samples is not possible.Additional applications training was offered to the customer and declined 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.

• 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: 15580271
• Report Number: 2520313-2022-00030
• Device Sequence Number: 15070550
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860(11)190319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/11/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 83 KG