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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5: patient information was not provided h11: livanova deutschland manufactures the s5 hlm.The event occurred in (b)(6), united states.Log files were provided: two errors have been identified (433 and 442), confirming the reported failure.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 a s5 heart lung machine roller pump 150 was showing 'motor fault' errors along with 2 yellow caution triangles.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
H11: the manufacturer technical service confirmed that the pump head needs to be replaced.As the customer did not agree, the device has been removed from service.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 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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23851728
• Report Number: 9611109-2025-90612
• Device Sequence Number: 9572234
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: SRD S5 CONSOLE FOR 4 PUMP
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 05/27/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/29/2026; 06/26/2026
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown