MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND VENOUS CLAMP ESSENZ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	12-80-40
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that, during a procedure, the essenz venous clamp shows 'wrench' symbol and could no longer be operated.Tthe cardio technician did not make any inputs to the hlm before.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 venous clamp.Customer didn't notice the errorcode/error number, history was overwritten by following cases (with no problems regarding evo) a livanova field service representative was dispatched to the facility to investigate the device and no problems found, the device was mechanically recalibrated and serial read out (real time device parameters and setting recording file) of the pump associated to the clamp was collected subsequent to present event, the problem reoccurred and error code indicating motor is defective was displayed (e2551).Before the error occurs, the perfusionist opened the evo lid during in a running case for a reposition of a kinked tubing.A recalibration could not be done afterwards and evo could be controlled in manual mode clamp will be requested to tssi for repair, customer has a spare evo on site for emergency if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Analysis of the cockpit log files confirmed the error message "vc defective" associated with error code 2551 was stored on the date of the event.The error code 2551 indicates a failure of the vc motor.The device was returned to the manufacturer site.The vc was functionally tested and no deviation was detected.As a preventive measure, the vc linear actuator and the manet frame were replaced and the unit was released back into regular service.Statistical database analysis did not reveal any adverse trend of reported failure mode.Based on the above facts, it cannot be ruled out that the root cause of the issue has been traced back to an intermittent failure of the vc motor.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: VENOUS CLAMP ESSENZ
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21122423
• Report Number: 9611109-2025-00016
• Device Sequence Number: 12646996
• Product Code: DTQ
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)240620
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 12-80-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown