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	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an electrical venous occluder (evo) gave an error message related to over-current at motor controller (low side) during priming.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).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
See intial report.
Additional Manufacturer Narrative
No evidence of service activity has been provided.Error code 1560 (rc overcurrent low side) indicates an overcurrent on the low side of the driver and it can be caused by: a faulty motor controller; a defective flat ribbon cable, that connects the hvb board to the microcontroller on the hva board; a faulty linear actuator.Complaints database review pointed out that no similar events have been submitted for this unit since its installation in 2020.Based on available information, the most likely root causes are a faulty motor controller or linear actuator or defective contacts on the ribbon cable, most likely due to wearing of the parts.Failure of electronic components can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.However, there is no concerning trend for this kind of failure.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.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: 17359206
• Report Number: 9611109-2023-00343
• Device Sequence Number: 6534427
• Product Code: DXC
• UDI-Device Identifier: 04033817900504
• UDI-Public: (01)04033817900504(11)200527
• 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
• Report Date (Section B): 07/15/2024

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: 06/22/2023
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2020
• 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