MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	SRD S5 DOUBLE ROLLER PUMP 85
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.- a.5.Patient information was not provided.H11: livanova field service technician dispatched on site did not confirm the issue after performing device operational tests, and no parts replacement occurred.Field service technician did not exclude pump over-occlusion by user as possible cause of the event.Complaints database review revealed no further similar events since unit¿s installation.No concerning trends related to reported failure mode was detected.Based on the investigation findings, it cannot be ruled out that incorrect pump settings by the user (e.G., an over-occlusion) led to the reported event.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
Livanova deutschland received a report that, during procedure, a s5 double roller pump had an internal alarm.The message display read "internal temperature is too high".Reportedly, pump was not rotating smoothly but jerky.There was no patient involvement.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 24616385
• Report Number: 9611109-2026-90095
• Device Sequence Number: 9640476
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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 DOUBLE ROLLER PUMP 85
• Device Catalogue Number: 10-85-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown