MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA SMART SYSTEM; NAVINA SMART SYSTEM REGULAR

Model Number	69014
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that the smart system did not account correctly for the volume of fluid delivered to the patient.Specifically, the user observed that when the container was filled to approximately 650 ml and the system was set to deliver 400 ml, the container became empty while the device display indicated that only approximately 0.3 l had been delivered.No patient injury was reported.
Additional Manufacturer Narrative
The manufacturer received a complaint reporting that the smart system did not accurately account for the volume of fluid delivered.The user indicated that when the container was filled to approximately 650 ml and the system was set to deliver 400 ml, the container became empty while the device displayed approximately 0.3 l infused.No patient injury or adverse health consequences were reported.The device was subsequently returned and underwent technical evaluation.Testing was performed three times, and the reported issue was confirmed.Approximately 50 ml of fluid was dispensed during priming.Following device operation, approximately 800 - 810 ml of fluid was delivered prior to the system stopping and displaying 0.5 l infused.The total measured volume delivered, including priming, was approximately 850 - 860 ml.The investigation concluded that the device exhibited a malfunction of the flowmeter, resulting in under reporting of the delivered volume.This condition could potentially lead to unintentional over-delivery of fluid without user awareness.

• Brand Name: NAVINA SMART SYSTEM
• Common Device Name: NAVINA SMART SYSTEM REGULAR
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, se-43 121, molndal, sweden ; SW
• Manufacturer (Section G): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; molndal, se-43 121, molndal, sweden ; SW
• Manufacturer Contact: emad ramzi ; aminogatan 1; molndal; se-431 21, 0046 31 376 4000 ; SW
• MDR Report Key: 25133874
• Report Number: 3009632672-2026-00018
• Device Sequence Number: 9315775
• Product Code: KNT
• UDI-Device Identifier: 07333387028729
• UDI-Public: 07333387028729
• Combination Product (Y/N): N
• PMA/510(K) Number: K190977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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
• Device Model Number: 69014
• Device Catalogue Number: 6901440
• Device Lot Number: 202504250035
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Male