MAUDE Adverse Event Report: NUWELLIS, INC. AQUADEX SMARTFLOW

Model Number	120100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports device fluid removal was approximately 20 ml/hr high during dayshift, and approximately 40 ml/hr high during night shfit.Customer believes this may have contributed to the patient becoming hypotensive and requiring fluid administration.

• Brand Name: AQUADEX SMARTFLOW
• Common Device Name: AQUADEX
• Manufacturer (Section D): NUWELLIS, INC.; 12988 valley view rd; eden prairie MN 55344
• Manufacturer (Section G): NUWELLIS, INC.; 12988 valley view rd; eden prairie 55344
• Manufacturer Contact: steve sandoval ; 12988 valley view rd; eden prairie 55344 ; 9527637040
• MDR Report Key: 24714089
• Report Number: 3007137787-2026-00003
• Device Sequence Number: 5763581
• Product Code: KDI
• UDI-Device Identifier: 10853072007104
• UDI-Public: 10853072007104
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 120100
• Device Catalogue Number: 120100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female
• Patient Weight: 5 KG