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 Arrest (4461)
Date of Event	11/15/2022
Type of Reportable Event	Death
Event or Problem Description
Bayer medical care was notified that an alleged patient death occurred 2-3 hours following a procedure in which a medrad® stellant ct injection system was in use.The customer site reported the following information: " the patient with a medical history of aortic aneurysm underwent contrast examination for fever and respiratory disorder.As the patient felt sick, anaphylactic shock was suspected first.Subsequently, the patient experienced decreased blood pressure and respiratory arrest and then died in 2-3 hours.After the examination of the condition, it was judged that the cause of the death was blood and contrast medium injected into the lung.The facility reported that there was no malfunction of the stellant with certegra workstation used and the contrast medium injected to the patient was a non-bayer product." multiple attempts to obtain additional information, including an autopsy report, have been made; however further details have not been provided to date.
Additional Manufacturer Narrative
A system service check of the medrad® stellant ct injection system was offered to the customer and declined.The site continues to use the medrad® stellant ct injection system after the reported event with no further issues reported.According to the reporting radiological technologist, device malfunction was not suspected.The disposables that were in use during the procedure were requested for evaluation by product analysis, however, the disposables used during the procedure were not returned by the customer and therefore cannot be tested.In addition, the customer was unable to provide lot numbers for the disposables at issue.As a result, 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.

• 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: 15938905
• Report Number: 2520313-2022-00034
• Device Sequence Number: 20419752
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)170623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/08/2022

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: 11/15/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLANT DISPOSABLES, LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown