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

Model Number	85631829
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant flex ct injector, sn (b)(6), was completed on march 31, 2023 which confirmed that the injector was operating within bayer specifications.The stellant disposable set that was in use during the procedure was discarded by the site; therefore, they are 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 offer of additional clinical applications training has been made to the customer and we are awaiting their response.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
A 65-year-old female patient from the emergency room was undergoing a ct scan of the abdomen and pelvis with intravenous contrast enhancement while connected to a medrad® stellant flex ct injection system.During the injection, an undisclosed amount of air was visualized within the heart on the displayed images.The patient became unresponsive and was successfully resuscitated.Subsequently, the patient was transferred for hyperbaric treatment and was reported to have been discharged to a rehabilitation unit with no neurological deficits noted.Note: this event occurred on (b)(6) 2023 at which time few details were provided regarding the alleged incident.At that time, bayer medical care made multiple unsuccessful documented attempts to gain specific information related to the incident.However, on (b)(6) 2023 bayer received additional incident details after which the reportability determination was made.

• 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: 17670698
• Report Number: 2520313-2023-00021
• Device Sequence Number: 20385334
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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: 85631829
• Device Catalogue Number: SCT FLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female