MAUDE Adverse Event Report: NUWELLIS, INC. AQUADEX SMARTFLOW; ULTRAFILTRATION DEVICE

Model Number	A06163
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following is a direct quote from an email from the user from 11/05/2024: "we did a set change on a patient, and we started having uf weight mismatch alarms on the patient.We monitored the patient and the uf bag, and compared what the machine was set to pull.It did appear to have 100-200mls too much off in a 3.5 hour period.The patient was fine the entire time as we were watching for signs / symptoms of hypovolemia, etc.And had a strict critline set (which the patient's hct was increasing over this time and it did hit the limit)." subsequent communication with the user on 11/14/2024 provided information that they provided additional fluids to the patient in order to address the effects of unintentional removal of excess fluid.Analysis of the data logs from the associated machine indicate that twelve "uf weight mismatch" alarms occured during the relevant five hour period.The associated disposable blood circuit (tubing/filter set) was returned to nuwellis for analysis.The weight mismatch issue was able to be reproduced with this tubing set using a different console/machine, indicating a defect with this dispoable.

• Brand Name: AQUADEX SMARTFLOW
• Common Device Name: ULTRAFILTRATION DEVICE
• Manufacturer (Section D): NUWELLIS, INC.; 12988 valley view rd; eden prairie MN 55344
• Manufacturer (Section G): NUWELLIS, INC.; 12988 valley view rd; eden prairie MN 55344
• Manufacturer Contact: steven sandoval ; 12988 valley view rd; eden prairie, MN 55344 ; 9525637040
• MDR Report Key: 22133245
• Report Number: 3007137787-2024-00001
• Device Sequence Number: 12623716
• Product Code: KDI
• UDI-Device Identifier: 10853072007029
• UDI-Public: 10853072007029
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A06163
• Device Catalogue Number: 114156
• Device Lot Number: 22698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 1 MO
• Patient Sex: Unknown
• Patient Weight: 3 KG