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	12/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check of the stellant ct injector, serial number (b)(4) was completed on december 5, 2019 which confirmed that the injector was operating within bayer specifications.There was no evidence of equipment malfunction.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.Additional applications training was offered; however, the customer declined.The site continues to use the stellant ct injection system after the reported event with no further issues reported.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 patient was undergoing a ct scan while connected to a stellant ct injection system.During the injection, approximately 10-20cc of air was visualized on the subsequent images.The patient was asymptomatic; however, they were admitted to an inpatient unit for observation and was discharged to home the following day without further issue.

• 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
• MDR Report Key: 9474854
• Report Number: 2520313-2019-00062
• Device Sequence Number: 19497989
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization