MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLAT 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	Embolism/Embolus (4438)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system, serial number: (b)(6), was completed on may 13, 2023 which confirmed that the injector was operating within bayer specifications.The lot number for the disposables in use at the time of the incident was not provided; therefore, testing of retained samples was not possible.Multiple documented attempts have been made to gain specific information related to the reported event; however, these attempts have been unsuccessful.The offer of additional clinical applications training has been accepted by the customer and will be scheduled.The site continues to use the stellant ct injection system after the reported event with no further issues reported.In the event that additional information is obtained, a follow-up report will be submitted.The stellant 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 was notified of an alleged air injection that had occurred during a ct scan while the patient was connected to a medrad® stellant ct injection system (serial number: (b)(6).During the procedure, the customer reported that approximately 100ml of air was injected.Subsequently the patient was reported to have had difficulty breathing and was transferred to another facility for treatment in a hyperbaric chamber.The current status of the patient is unknown.

• Brand Name: STELLAT 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: 17092933
• Report Number: 2520313-2023-00015
• Device Sequence Number: 7690577
• Product Code: DXT
• UDI-Device Identifier: 00616258020792
• UDI-Public: (01)00616258020792
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/08/2023

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: 05/19/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• 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; Required Intervention
• Patient Sex: Unknown