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	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) had an excessive weight mismatch alarm after 40 hours of therapy.Nurse received "uf bag full" alarm.Nurse only emptied half the bag because it overflowed the container she was emptying.Nuwellis received a call about the weight mismatch, and we determined it was because she did not fully empty the uf bag before continuing therapy.The nurse then emptied the rest of the uf about 15 minutes later to have an empty bag.The call ended.17 minutes later we received another call saying that the patient is hypotensive and 100cc of fluid was pulled in those 17 minutes when uf is set at 30cc/hr.Blood returned, therapy discontinued, and pt stabilized with fluids.We asked the nurse if the uf pump cartridge was in clipped in place and she replied yes.However, when nurse was taking down the circuit, she noticed that the uf cartridge was indeed loose.We told her we will still want the circuit and console back at corporate to run diagnostics but the uf cartridge being loose can lead to over-pulling.

• 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
• MDR Report Key: 22133892
• Report Number: 3007137787-2024-00003
• Device Sequence Number: 8408517
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 3 MO
• Patient Sex: Unknown
• Patient Weight: 4 KG