MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 SINGLE ROLLER PUMP 150
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report stating that an s5 hlm roller pump 150 stopped running and its display went black during the procedure.The involved pump was used as an auxiliary suction pump.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: a livanova field service technician was dispatched on-site and found that the latching mechanism of the pump push button switch broke, allowing it to move to the off position.To solve the issue, the push button switch was replaced.Functional tests were performed and passed successfully.The involved roller pump was released back to its functions.The push button switch is a small, sealed mechanism that completes an electric circuit when it is pressed.When it is in the "on" position, a small metal spring inside makes contact with two wires, allowing electricity to flow.When it's off, the spring retracts, contact is interrupted, and current does not flow.If the switch does not properly latch, most likely its internal spring is faulty.Complaints database review revealed that no further issue has been submitted for this unit since its installation in 2019.Moreover, statistical data analysis hasn't identified any concerning trend for this specific failure mode.Based on the investigation findings, the root cause of the reported event is a faulty pump push button.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 ROLLER PUMP 150
• 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: 24399207
• Report Number: 9611109-2026-90058
• Device Sequence Number: 15889793
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/20/2026

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 SINGLE ROLLER PUMP 150
• Device Catalogue Number: 10-80-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 12/19/2018
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown