MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11.Livanova field service engineer was dispatched to customer facility, inspected the device and confirmed that a calibration error message has been displayed.Repair is requested at manufacturing site.
Event or Problem Description
Livanova deutschland received a report of an electronic venous occluder (evo) which did not function properly and an error message has been displayed.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: the evo clamp was returned to the livanova manufacturing site for repair.The device was cleaned and disinfected, pin point and mechanical calibration were carried out.Functional tests were performed and passed successfully, the unit was put back into service.The involved evo clamp was manufactured in 2024 and, according to the complaints database review, no further similar incidents have been reported in the past.Complaints database statistical analysis did not reveal any concerning trend related to reported failure mode.Based on the investigation findings, and considering that no hardware component was replaced, the most likely root cause of the event is a calibration drift in the force required to close the clamp that developed over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: EVO
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23666201
• Report Number: 9611109-2025-90559
• Device Sequence Number: 8927405
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)240424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/25/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 03/25/2026
• Date Device Manufactured: 04/24/2024
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown