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	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 hlm system.The event occured in (b)(6), united states reportedly, the unit was deemed at the end of its life.Livanova has 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 hlm roller pump was not functioning.The issue occurred during procedure there is no report of any patient injury.

• 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: 24144350
• Report Number: 9611109-2026-90021
• Device Sequence Number: 18364570
• 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): 06/25/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 06/25/2026
• Date Device Manufactured: 08/28/2015
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown