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	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, during a procedure, the s5 double roller pump 85 failed and shut off 10 second after being turned on (no flow).There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 double roller pump 85.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: complaints database review revealed no further similar events since affected s5 console installation.No concerning trend was highlighted for reported failure mode.Considering that the issue could not be reproduced and based on available information, the root cause cannot be definitively determined and reported event was considered an isolated event.Nevertheless, based on findings from investigations into similar cases, the possibility of emc interference or a temporary electrical anomaly cannot be excluded.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11 livanova field service engineer was dispatched to customer facility and could not confirm the issue.As a precautionary measure, the erc was replaced.Following successful functional testing, the device was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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 80004
• MDR Report Key: 21976561
• Report Number: 9611109-2025-90100
• Device Sequence Number: 9252669
• Product Code: DTQ
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)160406
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 12/19/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/15/2025; 11/21/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 11/18/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2017
• 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