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	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 roller pump 150 gave a motor controller fault error message every time the pump was turned on.Customer attempted to install the pump on another console and swap out the power outlets, but the issue persists.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.E.1.The country is (b)(6).H11: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in (b)(6).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
The issue has been resolved by removing the pump head and disconnecting all the socket cables from the board, then reinstalling the pump head and reconnecting the sockets.After this procedure, the pump has been tested, and no further errors have appeared.Most probably, the problem was due to a bad connection in one of the cable sockets.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: complaint database review revealed no further similar events since unit¿s installation.No concerning trend was highlighted for reported failure mode.Based on all evidence, the root cause of the reported event was traced back to a bad cable connection, which was definitively fixed by the field engineer during the service activity.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; 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: 22747201
• Report Number: 9611109-2025-90305
• Device Sequence Number: 14574942
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)220819
• Combination Product (Y/N): N
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2025

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 SINGLE ROLLER PUMP 150
• Device Catalogue Number: 10-80-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 11/21/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/17/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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