MAUDE Adverse Event Report: NUWELLIS, INC AQUADEX SMARTFLOW

Model Number	A06163
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Dehydration (1807)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is a follow-on to our manufacturer report # 3007137787-2024-00001, with the same patient ("patient 1").Customer reports that while on aquadex smartflow therapy, weight mismatch alarm occured on (b)(6) 2024; approximately 100 ml excess was pulled in 45 minutes.Customer reports "agitation restlessness" and that 2 boluses of fluid were ordered (10 ml/kg each).Ultrafiltration rate was dropped to zero in response to weight mismatch alarms.

• Brand Name: AQUADEX SMARTFLOW
• Common Device Name: AQUADEX
• Manufacturer (Section D): NUWELLIS, INC; 12988 valley view rd; eden prairie MN 55344
• MDR Report Key: 22133883
• Report Number: 3007137787-2024-00002
• Device Sequence Number: 18274276
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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?: 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: 11/16/2024
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: TO BE ASSIGNED
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 MO
• Patient Sex: Unknown
• Patient Weight: 3 KG