MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ VENOUS CLAMP; 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	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report related to a venous clamp issue during procedure.Even if 20% opening was requested, the clamp was 100% open.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz venous clamp.The incident occurred in angers, france.Through follow-up communication with customer, livanova learned that the issue was claimed by two users.One of them confirmed that he had correctly calibrated the involved venous clamp, while the other one has doubts about having done so.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: the essenz cockpit log files have been analysed and there is no data recorded on the date of the event.The claimed venous clamp (vc) was returned to livanova deutschland for investigation: the device was tested for proper function and no issue was found.Firmware update, mechanical calibration, and technical safety inspection checks were completed successfully, therefore the unit was returned to regular service.The claimed clamp was manufactured in 2024 and complaints database review revealed that the device was also complained about for rust residues on the venous clamp hinge due to an incorrect cleaning procedure followed by the customer.According to the complaints data statistical analysis, no adverse concerning trend has been detected for this specific failure mode.Based on the investigation, a hardware malfunction of the device can be ruled out and the root cause cannot be determined.
Event or Problem Description
See initial report.

• Brand Name: ESSENZ VENOUS CLAMP
• 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 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21353084
• Report Number: 9611109-2025-00046
• Device Sequence Number: 9003211
• Product Code: DTQ
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)240213
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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