MAUDE Adverse Event Report: MUNICH EVO; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	OCCLUDER
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an electronic venous occluder (evo) which did not function properly.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: through follow-up communications with field service engineer (fse), livanova learned that an error message reporting that occluder is faulty (1560) was displayed.The fse tested the unit and could not reproduce the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: based on follow up communications, livanova was informed that internal electronic components of the electronic venous occluder (evo) were replaced as a precautionary measure.A review of the service history for the affected device indicated that no prior occurrences of the reported event had been associated with the specific unit involved.As the reported issue could not be reproduced during on-site testing, and based on the information currently available, the event is considered isolated, while the root cause of the occurrence could not be conclusively established.Nevertheless, taking into account the outcomes of previous investigations into similar events, it cannot be excluded that a temporary and non-persistent malfunction of an internal component may be considered a potential contributing factor associated with the reported behavior.Based on the available information, the associated risk remains within the acceptable region.
Event or Problem Description
See initial report.

• Brand Name: EVO
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; 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: 23495440
• Report Number: 9611109-2025-90509
• Device Sequence Number: 21060564
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)150827
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: OCCLUDER
• Device Catalogue Number: 12-80-10
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown