MAUDE Adverse Event Report: LIVANOVA USA INC. S5 ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-80-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that a s5 roller pump 150, used as cardioplegia one (which had two tubes loaded into a single large pump head), stopped during procedure without giving any audible alarm or visual alert.The pump jam was noticed by a perfusionist at around 10:30 am, who resolved the issue immediately.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in sri lanka.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: the analysis of the device log file was conducted.Analysis confirmed there is no error message regarding pump overload (most likely a ¿fault in motor controller¿ code 433 or 442 would have been stored) that should be displayed in case of tubing jam in the raceway.Most likely the user identified the issue before the pump could detect the overload.Around 10:30 (from 10:22 to 10:33) there are some pump stops due to stop of master arterial pump, cardioplegia control (pressure or bubble sensor on cardioplegia) and also due to reached administration of the set dose of cardioplegia; also a pump stop due to cover opening was stored (most likely when perfusionist re-set the tubing).Based on the fact that no error was stored in the logs regarding overload of pump that are usually related to wrong tubing/foreign material in pump raceway/overocclusion and would have been expected in case of tubing jam, most likely, the pump was already stopped when perfusionist noticed the tubing jam that, however, did not cause the overload.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
From follow-up communications, it was learned that pump is currently in use with no further issue.A device service history review has been performed and identified that the unit was manufactured in 2017 and no other similar event has been reported, neither concerning trend has been identified.Based on the fact that no error was stored in the logs regarding overload of pump that are usually related to wrong tubing/foreign material in pump raceway/overocclusion and would have been expected in case of tubing jam, most likely the pump was already stopped by master pump, cardioplegia control and/or completed administration of dose when perfusionist noticed the tubing jam that was not yet at a level to cause overload.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 intial report.

• Brand Name: S5 ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w. 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22120448
• Report Number: 9611109-2025-00127
• Device Sequence Number: 12528418
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)170921
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 10/30/2025

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: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 10/24/2025
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2017
• 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