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

Model Number	86600129
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); Hemodynamic instability (4868)
Type of Reportable Event	Death
Additional Manufacturer Narrative
This investigation remains in progress.Once the investigation is completed, a follow-up report will be submitted.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
On april 10, 2024, bayer medical care inc.Was notified that a patient had died in (b)(6) 2024 during a right-heart catheterization procedure while connected to a medrad® avanta fluid management injection system (serial number unknown).
Event or Problem Description
On april 10, 2024, bayer medical care inc.Was notified of a patient death that occurred in (b)(6) of 2024 while the patient was connected to a medrad® avanta fluid management injection system (sn (b)(6)) during a right-heart catheterization to determine suitability for a tricuspid valve replacement.At an unspecified point during the study, the patient suddenly became unstable due to unknown clinical factors.The details of any medical intervention undertaken leading up to the patient's death are unknown, despite multiple attempts to gain this information.Bayer medical care inc.Has not received an autopsy report and/or cause of death statement.Although unrelated to the patient event above, the hospital staff further communicated that during the procedure, the hemodynamic waveform, as measured by a third party's pressure transducer connected to the medrad® single patient disposable set (spat) had dampened.
Additional Manufacturer Narrative
A system service check of the medrad® avanta fluid management injection system, serial number (b)(6), was performed on (b)(6) 2024, which confirmed that the injector was operating within bayer specifications.The medrad® spat and the multi-patient disposable set (mpat) 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.Additional applications training was provided by the bayer clinical performance team.In regard to the allegation of a dampened waveform, no further investigation was possible without returned disposable sets or identification of lot numbers.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: for udi data discrepancy/mismatch on previously submitted mdr and to ensure the device identification data is in alignment with gudid.

• 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: 19118267
• Report Number: 2520313-2024-00008
• Device Sequence Number: 15229426
• Product Code: DXT
• UDI-Device Identifier: 00616258021447
• UDI-Public: (01)00616258021447(11)220622
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 09/25/2024

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: 86600129
• Device Catalogue Number: AVA 500 TABL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 05/08/2024; Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/13/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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: Death
• Patient Sex: Unknown