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	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in bergen, norway.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 a electrical venous occluder (evo) gave an alarm during priming.The customer did not remember the exact error code and a reportable malfunction cannot be excluded.There was no patient involvement.
Additional Manufacturer Narrative
Livanova has received a report about an evo clamp returning an alarm.The perfusionist was not able to recall the error.No impact to patient.The evo was shipped to manufacturer for repair and the reported error was not confirmed.The nvmem was cleared and motor current was adjusted.Mechanical and pin point calibration were performed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar events have been reported.Since the issue was not reproduced, livanova believes the most probable root cause was an intermittent / temporary electrical fault, probably occurred between the encoder board and the flat ribbon cable.The risk is in the acceptable region.No corrective was deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H.10: the affected device was returned back to the manufacturer site for repair.The unit was disinfected, opened, cleaned, checked and tested.The reported error was not confirmed.The nvmem was cleared and motor current was adjusted.Mechanical and pin point calibration were performed.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.

• 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: 15427515
• Report Number: 9611109-2022-00465
• Device Sequence Number: 15334101
• Product Code: DWC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)180315
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 11/24/2022

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: 08/19/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 10/26/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/14/2022; 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2018
• 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