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

Model Number	ELCTRNC VENOUS OCCLDR COMPLETE
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5 patient information was not provided.H11 livanova deutschland manufactures the evo clamp, the issue occurred in india.A livanova field service engineer was dispatched to the customer facility to investigate the issue.Upon testing, the error was confirmed, and it was identified that the motor of the venous clamp is defective.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that essenz hlm displayed the error message "vc defective" associated with the evo clamp.The error area on the user interface was highlighted in red.Reportedly, the venous clamp (vc) was unable to operate in conjunction with the arterial pump while this error was present.Troubleshooting was performed, and the error temporarily cleared; however, it reappeared shortly thereafter.The issue occurred during the priming.There is no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
A review of the livanova complaints database indicates that no additional similar events have been reported for this unit, and no concerning trend has been identified.Error code 2551 indicates a defect in the venous clamp motor.Based on the investigation findings, the root cause of the event has been attributed to a faulty electromechanical component of the venous clamp motor.The risk assessment is in the acceptable region.No action is currently deemed necessary.

• 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 GMBH; lindberghstrasse 25; munich CO 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23672106
• Report Number: 9611109-2025-90567
• Device Sequence Number: 9753807
• Product Code: DWF
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)250930
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/28/2026

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 COMPLETE
• Device Catalogue Number: 12-80-00
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown