MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH EVO; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	ELCTRNC VENOUS OCCLDR UNIT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an electronic venous occluder clamp (evo) showing an error message on system panel.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the evo clamp.The incident occurred in boston, united states.Livanova field service engineer was dispatched on site, confirmed the event and replaced the affected clamp with a new one to solve the problem.A device service history review was performed and identified that the unit was manufactured in 2025 and no other similar events have been reported.Complaints statistical data analysis did not reveal any concerning there for this failure mode.Based on investigation findings and considering that the displayed error code is caused by photocell not connected or defective, it is reasonable to trace the most likely root cause back to defective photo sensors.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: EVO
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24740370
• Report Number: 9611109-2026-90125
• Device Sequence Number: 10421947
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)25051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: ELCTRNC VENOUS OCCLDR UNIT
• Device Catalogue Number: 12-80-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown