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

Model Number	60726807
Health Effect - Clinical Codes	Air Embolism (1697); Patient Problem/Medical Problem (2688)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service performed a check of the injector and found it to perform to specifications.The subject disposables used during the injection were discarded at the site and the site was unable to provide the lot numbers.The site declined clinical applications assistance.This information does not constitute an admission that the device, the company or its employees caused or contributed to this reportable event.
Event or Problem Description
The customer reported the following: a (b)(6) year old female with a history of a periumbilical abscess underwent a ct of the abdomen and pelvis with contrast while connected to a stellant injector (serial number (b)(4)).Post injection, the radiologist visualized an indeterminate amount of air in the right ventricle on the images.No unusual (technical) issues were reported during the procedure to explain the presence of air.The patient was asymptomatic.The patient was kept for 24 hour observation and discharged to home the next day.

• 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
• MDR Report Key: 7227628
• Report Number: 2520313-2018-00019
• Device Sequence Number: 19138214
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)170825
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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: 60726807
• Device Catalogue Number: SCT D W/ CERTEGRA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/30/2018
• 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
• Patient Age: 27 YR