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

Model Number	60726742
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A system service check report of the medrad® avanta fluid management injection system (serial number (b)(6) ) has been scheduled.The medrad® single-patient disposable set (spat, lot number unknown) and the multi-patient disposable set (mpat, lot number unknown) in use during the incident were not saved.Lot numbers for the subject disposables were not provided; therefore, testing of retained samples is not possible.This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.The avanta fluid management system operation manual cautions the user as follows: "warning: expel all air from the syringe, drip chambers, connectors, tubing, transducer, and catheter before connecting the system to the patient." 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
Bayer medical care inc.Was informed that a 60-year-old male experienced an alleged air injection during a heart catheterization procedure while connected to a medrad® avanta fluid management injection system (sn (b)(6)).The customer reported that an undisclosed amount of air was visualized after a contrast injection in the left coronary system.Following the event, the patient went into cardiac arrest, was immediately resuscitated and was successfully stabilized.The patient is reported as doing well.
Event or Problem Description
Bayer medical care inc.Was informed that a 60-year-old male experienced an alleged air injection during a heart catheterization procedure while connected to a medrad® avanta fluid management injection system (sn (b)(6)).The customer reported that an undisclosed amount of air was visualized after a contrast injection in the left coronary system.Following the event, the patient went into cardiac arrest, was immediately resuscitated and was successfully stabilized.The patient is reported as doing well.
Additional Manufacturer Narrative
A system service check of the medrad® avanta fluid management injection system, serial number (b)(6), was performed on (b)(6) 2025, which confirmed that the injector was operating within bayer specifications.The medrad® single-patient disposable set (spat, lot number unknown) and the multi-patient disposable set (mpat, lot number unknown) in use during the incident were not saved.Lot numbers for the subject disposables were not provided; therefore, testing of retained samples is not possible.The offer of additional applications training was accepted by the customer and will be scheduled this month.The avanta fluid management system operation manual cautions the user as follows: "warning: expel all air from the syringe, drip chambers, connectors, tubing, transducer, and catheter before connecting the system to the patient." 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; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: jason johnson ; 1 bayer drive; indianola, PA 15051 ; 4124063016
• MDR Report Key: 21218217
• Report Number: 2520313-2025-00001
• Device Sequence Number: 19703045
• Product Code: DXT
• UDI-Device Identifier: 00616258008578
• UDI-Public: (01)00616258008578(11)180822
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K050456
• 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,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• 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: MULTI-PATIENT DISPOSABLE SET (MPAT).; MULTI-PATIENT DISPOSABLE SET (MPAT).; SINGLE-PATIENT DISPOSABLE SET (SPAT).; SINGLE-PATIENT DISPOSABLE SET (SPAT).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male