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	Extravasation (1842)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.
Event or Problem Description
Bayer medical care was notified of an extravasation that occurred during an enhanced ct scan on an elderly female patient while connected to a stellant ct injection system.The customer reported an undisclosed amount of contrast had extravasated during the procedure at the patient's iv (intravenous site) catheter location.The iv catheter was subsequently removed and a new one was started after which the injection and scan were successfully completed.Post procedure, the patient was treated at an outpatient department.The current status of the patient is unknown.
Additional Manufacturer Narrative
A system service check of the stellant ct injector, serial number (b)(6), was completed on july 29, 2020 which confirmed that the injector was operating within bayer specifications.There was no evidence of equipment malfunction.The disposables that were in used during the event were discarded.The customer confirmed that the disposables were supplied by a third party vendor and were not bayer/medrad products.The stellant ct injection system operation manual cautions the user as follows: patient injury could result from using improper accessories.Use only accessories and options provided by bayer designed for this system.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.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola, pa
• MDR Report Key: 10282914
• Report Number: 2520313-2020-00027
• Device Sequence Number: 2853337
• Product Code: DXT
• UDI-Device Identifier: 00616258020860
• UDI-Public: (01)00616258020860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/03/2020

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: 85937286
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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: Hospitalization; Other; Required Intervention