MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. AVANTA FLUID MANAGEMENT SYSTEM; ANGIOGRAPHIC INJECTOR

Model Number	60726742
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	09/26/2025
Type of Reportable Event	Death
Event or Problem Description
The following information was reported to bayer.A patient was undergoing a coronary angiogram while connected to a medrad® avanta fluid management system (serial number (b)(6).During the first injection of contrast, air was visualized on the displayed images after which non-specified emergency treatment was immediately initiated, and cardiopulmonary resuscitation (cpr) / advanced cardiovascular life support (acls) was performed by the medical team.Despite these efforts, the patient could not be resuscitated and ceased to breathe.
Additional Manufacturer Narrative
A system service check of the medrad® avanta fluid management system (serial number (b)(6) was completed on october 6, 2025, at which time the equipment was confirmed to be operating to specification.The offer of additional clinical applications was declined by the customer.The medrad® avanta fluid management system operation manual cautions the user as follows: minimizing air embolization risks: 1.Warning: do not inject air · air embolism hazard: injury or death can result.· observe changes in fluidots® indicators, for medrad® syringes.· expel air from syringe/disposables.- read operation manual.2.Do not connect a patient to the injector or attempt an injection until all air has been removed from the syringe and fluid path.3.Expel all air from the syringe, drip chambers, connectors, tubings, transducer, and catheter before connecting the system to the patient.Carefully read the instructions for loading and the use of fluidots® indicators (where applicable) to reduce the chance of air embolism.4.Disconnect the patient from the avanta single-patient disposable set (spat) if a system malfunction occurs.5.Verify that the fluid path is free of air before attempting an injection.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: AVANTA FLUID MANAGEMENT SYSTEM
• Common Device Name: ANGIOGRAPHIC INJECTOR
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 23582317
• Report Number: 2520313-2025-00028
• Device Sequence Number: 15835984
• Product Code: DXT
• UDI-Device Identifier: 00616258008578
• UDI-Public: (01)00616258008578(11)171201
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K050456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 60726742
• Device Catalogue Number: AVA 500 PEDL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2017
• 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: MPAT - LOT NUMBER UNKNOWN; SPAT - LOT NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG