MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN ELECTRICAL VENOUS OCCLUDER (EVO); CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	12-80-40
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that the electrical venous occluder (evo clamp) showed poor fine tuning control (adjustment) with small hose diameters (3/16 and 1/4) during a procedure.No issue was observed for other (bigger) tubing diameters.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: when starting and stopping the evo, there is still 50 to 80% backflow at 1% clamp was successfully zero-calibrated.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Complaint database review reveal an issue regarding essenz venous clamps that were not completely occlusive.According to customer, issue was previously noticed also on s5.This was traced back to an operator error during the motor current adjustment.To prevent further occurrence the dhr and manufacturing instruction of electrical venous clamp for essenz and s5 was updated and operator retrained.Complained clamp was not returned for testing since customer could still use the clamp and the reported issue was more related to a dissatisfaction with closure control than a malfunction of the device.Tests were performed on similar clamp to verify behavior.After vc calibration, similar issue was reproduced also on testing clamp: with 1/4" and 3/16" tubing the flow at 1% opening was not around the 50-80% as reported by customer but still significant.No issue with closure of 3/8" tubing was confirmed on the other side, as reported by customer.Further tests were performed on three similar venous clamps to evaluate closure behavior of the venous clamps since customer reported that the issue was generally noticed both on essenz and s5 clamps.Test found a non-linear behavior with 3/8" tubing, while with small tubing the clamp closure behavior was more linear.However, at small opening percentages it was confirmed a relevant residual flow (around 20%) of the maximum flow established).Best closing behavior was obtained with clamp manufactured after implementation of above described corrective actions.Taking into account that similar behavior was confirmed on other similar devices to a lesser extent and that the complained venous clamp was manufactured before implementation of the above mentioned corrective actions, it cannot be ruled out that closure control with small tubing is sub-optimal and in reported case there might have been a contribution of improper motor current adjustment.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: SORIN ELECTRICAL VENOUS OCCLUDER (EVO)
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20125732
• Report Number: 9611109-2024-00395
• Device Sequence Number: 3265447
• Product Code: DWF
• UDI-Device Identifier: 04033817903093
• UDI-Public: (01)04033817903093(11)230526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082344
• 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): 01/24/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• 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