MAUDE Adverse Event Report: NUWELLIS AQUADEX SMARTFLOW

Model Number	120100
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Codes	Hypovolemia (2243); Convulsion/Seizure (4406)
Date of Event	01/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was on therapy and during the night, the nurses got several weight scale mismatch alarms.User estimated the patient lost 300mls in 30 mins.

• Brand Name: AQUADEX SMARTFLOW
• Common Device Name: AQUADEX
• Manufacturer (Section D): NUWELLIS; 12988 valley view rd; eden prairie MN 55344
• Manufacturer (Section G): NUWELLIS; 12988 valley view rd; eden prairie 55347
• Manufacturer Contact: emma deroode-george ; 12988 valley view rd; eden prairie, MN 55344
• MDR Report Key: 24471749
• Report Number: 3007137787-2026-00002
• Device Sequence Number: 10277563
• Product Code: KDI
• UDI-Device Identifier: 10853072007104
• UDI-Public: 10853072007104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: 02/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: 2 MO
• Patient Sex: Female
• Patient Weight: 3 KG