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	04/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).It was reported that the customer had some issues with the device in the past and following to that the clamp was checked and found to be properly working.At the time, the device was re-calibrated and nvmem cleared.The device worked as per specifications and was returned to the customer.However, it was communicated that despite the clamp worked well for some time, there were errors sometimes during calibration and sometimes during work until recently reported error associated to the clamp encoder.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that electrical venous occluder (evo) gave some problems sporadically.Reportedly, the clamp displayed errors during calibration and also during use and recently gave an error code associated to the clamp encoder.There was no report of patient injury.
Additional Manufacturer Narrative
H.10: through follow-up communication livanova learned that the customer only recall about error associated to the clamp encoder and not other errors.The affected device was returned to the manufacturer site for repair and upon testing the reported issue could not be reproduced.However, the clamp encoder and the ribbon cable were replaced as potentially involved components.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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
Based on available information and similar reports from other customers, it cannot be ruled out that the most likely root causes was an intermittent faulty connection between the encoder board and the ribbon cable.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14373719
• Report Number: 9611109-2022-00241
• Device Sequence Number: 13948745
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)170901
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 05/11/2022

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: 12-80-10
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 05/12/2022; 06/21/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/09/2022; 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2017
• 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