MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	S5 MIN.I.
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 console.The incident occurred in london, united kingdom.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 s5 pump gave a motor controller error message during bypass.Customer was not able to turn the pump via the dial, no revolutions possible.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D.4.Item code, sn and udi of the pump have been provided and relevant fields updated.H.4.Sn of the pump have been provided and relevant field updated h.11.The pump has been removed from the customer premises.Technical service was unable to reproduce the fault code/alarm and will further investigate the pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Technician inspected the unit and could not reproduce any issue.However, the boards in the pump were replaced as a precaution.Functional tests were performed according to tsi and unit was returned to service.They use the s5 device every day, so it was not possible to get a serial read-out.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported, neither concerning trend has been identified.Based on all the gathered information and the review of service manual, the reported issue could be related to temporary electrical failure definitively fixed by service technician throughout the boards replacement.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: S5 CONSOLE
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, 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: 20459259
• Report Number: 9611109-2024-00472
• Device Sequence Number: 12953818
• Product Code: DTQ
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)181210
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• 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): 01/09/2025

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: S5 MIN.I.
• Device Catalogue Number: 10-88-60
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/13/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 12/12/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• 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