MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND EVO; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	OCCLUDER
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the evo.The incident occurred in (b)(6) germany.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
Livanova deutschland received a report that an electronic venous occluder (evo) did not close correctly during priming.There was no patient involvement.
Additional Manufacturer Narrative
The device was returned to manufacturer for investigation.Prior to test run, no error could not be confirmed in the electronic venous occluder.Device was cleaned and disinfected, visual check was performed and no issue identified, technical safety inspection performed correctly, calibration and test run completed correctly.During complete procedure no error occurred.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H 11: the device was returned to manufacturer (livanova munich) for investigation.Prior to test run, no error could not be confirmed in the electronic venous occluder.Device was cleaned and disinfected, visual check was performed and no issue identified, technical safety inspection performed correctly, calibration and test run completed correctly.During complete procedure no error occurred.The device was manufactured in 2017 and a review of similar complaints revealed another event occurred in 2019.During that investigation the technician failed to reproduce the issue.Taking into account all the above facts and that the unit was found properly working by the authorized livanova field service technician, it cannot be ruled out that use condition at the customer site (e.G.Evo clamp not properly connected to its control panel, wrong tube material used) could have led to the reported event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: 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: 20417061
• Report Number: 9611109-2024-00464
• Device Sequence Number: 8221782
• Product Code: DWF
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)171103
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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: OCCLUDER
• Device Catalogue 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: 09/13/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 11/29/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 11/20/2024; 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2017
• 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