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

Model Number	28-95-70
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the knobs on an electronic venous occluder (evo) control unit no longer responded when turned.The issue occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the evo.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.During inspection it was found that the knob screws were loose.Therefore, the work was completed by retightening the screws, and normal operation was confirmed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Complaints database analysis revealed no similar event since unit installation in 2016.Based on the result of service activity, the root cause of the reported failure can be traced back to sceews that become loose over the time potentially as consequence of: · vibration: continuous or repetitive movement can cause vibrations that loosen screws over time.These vibrations can gradually loosen the fastener's grip on the material it's securing.· thermal expansion and contraction: changes in temperature can cause materials to expand or contract.This expansion and contraction can exert pressure on screws, leading to loosening over time.· material wear: mechanical parts in movement experience wear and tear over time.As materials wear down, the fit between components may become less precise, leading to increased movement and potential loosening of screws.· environmental factors: exposure to moisture, chemicals, or other environmental factors can corrode screws or the material they're fastened into, compromising their grip and causing loosening.· fatigue: screws, like other materials, can experience fatigue over time, especially if subjected to repetitive stress or loading.Fatigue can weaken the material and lead to loosening of the screw.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• 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: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21322654
• Report Number: 9611109-2025-00044
• Device Sequence Number: 7918548
• Product Code: DWF
• UDI-Device Identifier: 04033817900801
• UDI-Public: (01)04033817900801(11)161117
• 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): 04/30/2025

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: 28-95-70
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2016
• 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