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

Model Number	SRD S5 CONSOLE FOR 3 PUMP
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11: livanova field service technician dispatched on site for inspection confirmed the issue and found the knob had a loose screw.The screw was tightened, functional checks were carried out and passed successfully, therefore, the unit was put back into regular service.Complaints database review revealed that no further similar event has been reported for this unit since its installation in 2016.No concerning trend related to reported failure mode was detected.Based on investigation findings, the root cause of the issue has been traced back to a loose screw, likely due to repetitive stresses on the knob.The wearing of electro-mechanical devices can be originated by the specific use condition at customer site that may have contributed to the event, such as movements or liquids penetration.No other specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.
Event or Problem Description
Livanova deutschland received a report that the knob of an arterial pump of an s5 heart-lung machine (hlm) turned inconsistently.There is no report of any patient injury.

• Brand Name: S5 CONSOLE
• 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
• MDR Report Key: 24598108
• Report Number: 9611109-2026-90091
• Device Sequence Number: 9499896
• 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
• Report Date (Section B): 03/13/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Date Device Manufactured: 07/04/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown