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	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report of an electronic venous occluder (evo) which could not fully close when the device opening value was set to 0%.The event occurred during setup.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental 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: 50691724
• Report Number: 9611109-2026-90420
• Device Sequence Number: 5891747
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• 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
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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
• Operator of Device: Health Professional
• Device Model Number: ELCTRNC VENOUS OCCLDR UNIT
• Device Catalogue Number: 12-80-10
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 07/12/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown