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

Model Number	S5 SINGLE ROLLER PUMP 150
Medical Device Problem Codes	Pumping Stopped (1503); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that, the s5 single roller pump 150 displayed error motor control failure (e441) and the screen temporarily became black.The issue occurred during procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.H11: livanova deutschland manufactures the s5 roller pump 150, the incident occurred in china.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11 follow-up communication revealed that the pump stopped during the procedure, prompting the physician to replace it with another pump and successfully complete the procedure.Furthermore, it was noted that the console was not equipped with the ground cable.The instructions for use (ifu) strongly recommends verifying the operating theatre environment for potential emissions from high-frequency devices and ensuring that the potential equalization cable is always connected to earth.A livanova field service engineer was dispatched to the customer¿s facility to inspect the device.The reported issue could not be reproduced; all functional tests were successfully completed, and the unit was returned to service.An analysis of the complaints database confirmed that no similar events have occurred since the unit¿s installation.Additionally, a review of post-market data did not identify any concerning trends.The watchdog reset function in s5 devices is an intentional protective feature of the system.Distortion of the can bus signal can result from electromagnetic interference or, in rare cases, a microprocessor failure on electronic boards.Given that no deviations were identified during the technical inspection and no ground table was mounted on affected console, an electronic board malfunction can be reasonably excluded.Based on all the gathered information, the most likely root cause of the event is an isolated external interference from an unidentified high-frequency device.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.

• Brand Name: S5 ROLLER PUMP 150
• 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 GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; arvada, CO
• MDR Report Key: 23325595
• Report Number: 9611109-2025-90447
• Device Sequence Number: 10616733
• Product Code: DTQ
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)240717
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: S5 SINGLE ROLLER PUMP 150
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/01/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown