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

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received report that the rpm of the s5 hlm centrifugal pump was not fully controllable.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided h11 livanova deutschland manufactures the s5 hlm device, the event occurred in the united states.Livanova field service engineer was dispatched to the facility and did not confirm the issue.After performing all the functional tests with positive results, unit was sent back in its expected functions.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A review of the device¿s service history indicated that no previous events have been reported for this unit.No adverse trends associated with this type of failure mode has been detected.Based on the investigation findings and the inability to reproduce the event, a definitive root cause cannot be determined.Nevertheless, potential contributing factors may include: - fluid-dynamic changes in the circuit (e.G., momentary preload/afterload variations), - electromagnetic interference or external disturbances affecting the control signal, the risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 HLM
• 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: 23645249
• Report Number: 9611109-2025-90552
• Device Sequence Number: 9829385
• 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: SRD S5 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 04/16/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown