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	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an electrical venous occluder (evo) gave an error message during procedure.No addition information is available.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in columbus, district of columbia.A livanova field service representative was dispatched to the facility to investigate the device and could reproduce the reported issue.A pinpoint calibration of the unit was performed and functional test carried out without failure.The evo clamp has been ordered and will be replaced anyway as per customer's request.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
After present occurrence, even if issue was re-solved with pinpoint calibration, customer decided to remove from service current unit and replaced it.The unit was manufactured in 2015 livanova complaint database review revealed that one further similar issue on this evo serial number occurred in 2022, another similar occurrence on different evo and same hlm console occurred in march 2024.Accordingly customer reported he experienced a previous calibration issue that was solved with pinpoint calibration.No further information about involved evo has been provided, nor if the customer replaced on its own the evo on the unit after first occurrence.Based on all the gathered information, it is reasonable to assume that the error message was related to a calibration failure of the evo that must be performed before procedure.It cannot be ruled out that the most likely root cause for reported event is a drift in calibration, that may also be related to user rough manipulation of the part when setting the tubing and/or wrong tubing material used.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19928361
• Report Number: 9611109-2024-00353
• Device Sequence Number: 18178119
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)191204
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• 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