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

Model Number	60726807
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	01/30/2020
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 january 31, 2020 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 and unavailable for evaluation.The customer was unable to provide the lot number of the disposables used during the incident; therefore, testing of retained samples was not possible.The offer of additional clinical applications training has been made to the customer and we are awaiting their response.The site continues to use the stellant ct injection system after the reported event with no further issues reported.
Event or Problem Description
Bayer medical care was notified of an extravasation that occurred during an enhanced ct scan while a patient was connected to a stellant ct injection system.The customer reported that approximately 220ml of fluid extravasated (120 ml contrast and 100ml saline) an icepack was applied to the affected extremity and the patient was re-evaluated the following day by a surgeon who determined that they should continue to apply ice as needed.No further medical intervention was necessary.

• 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: 9739549
• Report Number: 2520313-2020-00006
• Device Sequence Number: 16762912
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943
• 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): 02/21/2020

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: 60726807
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/21/2020
• 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: Other; Required Intervention