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

Model Number	S5 HLM
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an erc clamp in use with a s5 hlm machine was not operating correctly, during priming.There is no patient involvement.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11.Livanova deutschland manufactures the s5 hlm, the event occurred in united kingdom.Livanova field service engineer was dispatched to the customer facility and successfully retrieved the log files.Analysis of the serial readout files confirmed the reported issue since three arterial clamp timeout events were recorded on the date of the incident.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: 23701990
• Report Number: 9611109-2025-90568
• Device Sequence Number: 10629155
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210130
• 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): 06/24/2026

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 HLM
• Device Catalogue Number: 48-40-00Z
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown