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

Model Number	6072680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A bayer service representative performed a system checkout of the stellant injector system (serial (b)(4)) and found the system was performing to specifications.The stellant injector system has been in use daily following the checkout.The disposables used in the reported occurrence were discarded by the customer and are unavailable for evaluation; however, lot numbers were able to be provided.Bayer product analysis received and functionally tested retained samples of lot numbers 8578714 (syringe) and 8413974 (tubing) and found the disposables performed as intended and to specifications.The customer has accepted an offer for additional applications training and a site visit by a bayer clinical support specialist will be scheduled.
Event or Problem Description
A bayer representative reported the following: a (b)(6)-year-old, female emergency room patient who reportedly fell down a flight of stairs was undergoing multiple ct scans of the body with and without contrast media utilizing a stellant injector to rule out injury post fall.An indeterminate amount of was observed in the right atrium, main pulmonary artery, and brachiocephalic vein.The patient was placed in trendelenburg position for 24 hours and admitted as an inpatient.The patient is reported to be recovering and is expected to be discharged from the hospital soon.

• 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: 10677425
• Report Number: 2520313-2020-00038
• Device Sequence Number: 2757588
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: 6072680
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 84