MAUDE Adverse Event Report: WELLSPECT HEALTHCARE NAVINA CLASSIC SYSTEM; NAVINA CLASSIC SYSTEM SMALL

Model Number	69007
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer conducted an investigation based on the information provided by the user.The complainant reported that irrigation fluid flowed through the control unit without manual pumping and at a faster than expected rate when the water control switch was in the "on" position.The user reported that the patient experienced transient vomiting episodes during use.No medical intervention was required.The device involved in the event was not returned despite multiple requests; therefore, no functional or performance testing could be conducted to verify the reported issue or determine a definitive root cause.The investigation relied on user-provided information, including detailed descriptions of the event and device usage conditions.A review of the manufacturing and batch records for the reported lot was performed.This review did not identify any deviations, nonconformities, or anomalies that could be associated with the reported issue.The complaint indicates a potential malfunction related to fluid flow rate or pump/control unit performance.However, due to the absence of the returned device and lack of objective test data, the reported issue could not be confirmed, nor could a specific root cause be established.Based on the available information, it cannot be excluded that the device may have contributed to the event.No similar trends or signals have been identified that would indicate a broader systemic issue at this time.
Event or Problem Description
A complaint was received involving a navina classic irrigation system control unit.The user reported that upon replacing the pump and tubing set, irrigation fluid flowed through the system without manual pumping when the water control switch was in the "on" position.The reported flow rate was significantly higher than expected, with approximately 300 ml of irrigation fluid infused in less than one minute, compared to the typical infusion time of 2-3 minutes.During use of the affected control unit, the patient (pediatric user with spina bifida) experienced episodes of vomiting during irrigation, including one instance of emesis on one day and two instances on another day.No medical treatment was sought, and no hospitalization or serious injury was reported.The user discontinued use of the new control unit after three days and resumed use of a previous control unit with the same tubing, after which the issue was not observed.

• Brand Name: NAVINA CLASSIC SYSTEM
• Common Device Name: NAVINA CLASSIC SYSTEM SMALL
• 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; p.o. box 14; mölndal, SE-43- 121 ; SW SE-43 121
• MDR Report Key: 25239447
• Report Number: 3009632672-2026-00020
• Device Sequence Number: 13192931
• Product Code: KNT
• UDI-Device Identifier: 07333387026589
• UDI-Public: 07333387026589
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 69007
• Device Catalogue Number: 6900740
• Device Lot Number: 670882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2026
• 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: Other
• Patient Sex: Female