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

Model Number	12-80-10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that when the power supply was turned on an electrical venous occluder (evo) clamp gave an error code related to faulty encoder.After that, the device was rebooted several times and error disappeared.The issue occurred at setup.There was no patient involvement.
Additional Manufacturer Narrative
Patient identifier: there was no patient involvement.Concomitant medical products: livanova deutschland manufactures the electrical venous occluder (evo) clamp.The incident occurred in gifu, japan.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: a livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.Calibration by flash firmware was performed.Subsequent functional verification testing through long-term running was completed without issues and the unit was returned to service.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2016.The reported malfunction can be caused by: an electronic venous occluder (evo) clamp harware issue; a faulty communication between the encoder board and the ribbon cable; an incorrect tubing size or material used by the customer.Based on technical service intervention, hardware malfunction can be excluded as cause of the event.It cannot be ruled out that an incorrect tubing size / material could have contributed to the reported event.

• Brand Name: ELECTRICAL VENOUS OCCLUDER (EVO)
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 16252159
• Report Number: 9611109-2023-00042
• Device Sequence Number: 20219515
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)160907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 12-80-10
• 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: 12/31/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2016
• 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