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	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the stellant flex ct injector, serial number (b)(6), was declined by the customer.The disposables that were in use during the alleged incident were discarded by the site.The lot number was not provided; therefore, testing of retained samples was not possible.The offer of additional clinical applications training has been accepted and will be scheduled.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
The customer reported the following: a 23-year-old female patient with a history of sickle cell disease was undergoing an enhanced ct scan of the chest for suspected pulmonary arterial air emboli while connected to a medrad® stellant flex ct injection system (sn (b)(6).During the contrast injection, the technologist noticed that there was no increase in pressure, so the procedure was halted and, when evaluating the patient, the technologist observed that there had been a leakage of contrast onto the table behind the patient's head.After replacing the disposables, the procedure was completed without incident.The radiologist reviewed the images and reported that air was visualized.The patient was subsequently placed into hyperbaric oxygen protocol with administration of high flow oxygen and close observation.A repeat ct scan was performed, and the patient is reported to have been discharged with no further issues reported.

• 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: 19171735
• Report Number: 2520313-2024-00009
• Device Sequence Number: 7304212
• Product Code: DXT
• UDI-Device Identifier: 00616258011219
• UDI-Public: (01)00616258011219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/24/2024

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): Initial
• Initial Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2020
• 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
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 56 KG