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

Model Number	SRD S5 CONSOLE FOR 3 PUMP
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided h11 livanova deutschland manufactures the cp5 system, the event occurred in the united states.Livanova field service engineer dispatched onsite inspected the control panel for any visible signs of damage or loose connections.No such issues were identified during the inspection.Subsequently, the cp5 panel was reconnected, and functional checks were performed.The unit was then tested for several hours and no anomalies were observed, therefore it was sent back to customer in its expected functions.If any additional information is received, a follow up report will be submitted.
Event or Problem Description
Livanova deutschland received a report indicating that, during procedure, a cp5 console abruptly powered off.Reportedly, the console resumed normal operation after being turned back on.As a precautionary measure, all connecting cables were disconnected and reconnected to ensure that no loose connections were present.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: 23876372
• Report Number: 9611109-2025-90621
• Device Sequence Number: 21245166
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/26/2026

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 3 PUMP
• Device Catalogue Number: 48-30-00
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 08/18/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown