MAUDE Adverse Event Report: MUNICH 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	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 roller pump 150.A field service engineer was dispatched the customer site to troubleshoot the problem and found no malfunction.Inspection of internal components did not reveal any damage and/or loose connection.However, they couldn¿t rule out circuit board failure or whether it was accidental situation.A failure of circuit boards cannot be excluded.No part has been replaced yet.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that the s5 roller pump alarmed motor overspeed, then showed a fault in the motor controller (429), causing the pump head to stop working during use, there was no report of patient injury.
Additional Manufacturer Narrative
H11: the customer provided a photo confirming error code 429.However, the log files submitted were not extracted from the affected pump, and their origin could not be verified.The field service technician was unable to retrieve additional logs to determine whether other alarms occurred.A review of the technical service manual identified error code 429 as typically related to a defect in the flat ribbon cable of the hms board.This error may also occur alongside runaway faults error codes 437 and 449, which indicate excessive pump speed.Based on the available information, one of these faults likely preceded the motor controller error.A review of the device¿s service history confirmed that the unit was manufactured in 2021.No similar events have been reported, and no concerning trends were identified.Considering all the above information, specifically the inspection results and the fact that no parts were replaced, the most likely root cause is a temporary or intermittent internal electrical fault¿such as a false contact within the hms motor controller board or its ribbon cable¿possibly due to oxidation accumulated over time as a result of environmental conditions.
Event or Problem Description
See initial report.

• Brand Name: S5 ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MUNICH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22139194
• Report Number: 9611109-2025-90144
• Device Sequence Number: 15234396
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)210318
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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
• Device Model Number: SRD S5 SINGLE ROLLER PUMP 150
• Device Lot Number: 10E21756
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2021
• 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