MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	S5 ROLLER PUMP 150
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided h11 livanova deutschland manufactures the s5 roller pump 150, the event occurred in the united states.Livanova field service engineer was dispatched to customer facility, confirmed the issue and to fix it, the motor controller board has been replaced.After performing all the functional tests with positive results, unit was sent back to customer in its expected function.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 the s5 hlm showed the error message motor control failure, related to roller pump 1.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A review of the device¿s service history was performed and no previous report of similar events was identified since the unit's installation.Further livanova complaint database review and corresponding statistical analysis did not identify any adverse trends associated with this type of issue.Based on the investigation findings, the root cause of the event has been attributed to a faulty motor control board, likely due to wear and aging of the component.Wear in electromechanical devices can be influenced by specific usage conditions at the customer site and may have contributed to the event; however, there is no concerning trend for this type of failure.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 ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24186655
• Report Number: 9611109-2026-90024
• Device Sequence Number: 7894113
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Device Model Number: S5 ROLLER PUMP 150
• Device Catalogue Number: 10-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 04/16/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown