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 Codes	Cardiac Arrest (1762); Respiratory Failure (2484)
Date of Event	03/28/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system (sn (b)(4)), was completed by bayer service on march 31, 2022, which confirmed that the injector was operating within specification.The disposables that were in use during the procedure were discarded by the site and lot numbers were unable to be provided; therefore, testing of retained samples is unable to be performed at this time.An offer for additional clinical applications training has been declined by the customer at this time.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 following information was reported to bayer service.A (b)(6) female undergoing a ct urogram suffered a mi (myocardial infarction) and passed away while connected to a medrad® stellant ct injection system (sn (b)(4)).Following the contrast injection, the patient's medical status declined.She suffered respiratory distress and subsequent mi.The emergency response team was called and life saving measures were initiated; however the patient ultimately passed away.The customer stated that the staff do not associate the use of the injector to be involved with the death of the patient.An autopsy statement has been requested; however one has not been provided to date.

• 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
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: susan sherwin ; 1 bayer drive; indianola, PA 15051 ; 7249408678
• MDR Report Key: 14043035
• Report Number: 2520313-2022-00014
• Device Sequence Number: 6301717
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)170814
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Sex: Female