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

Model Number	10-88-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the s5 mast roller pump.A livanova field service representative was dispatched to the facility to investigate the device during investigation, it was found the roller pump 85 makes ticking noise and the ep-connector 6 is burned in the top pin.The device has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that, during priming, cardioplegia s5 mast roller pump stopped running.There was no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Despite serial read out (real time device parameters and setting recording file) of the pump were requested, these were not provided.The pump was returned to manufacturer for inspection, confirming that pump head was not turning and boards were corroded due to fluid penetration.To solve the problem, both boards and the pump head need to be replaced.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.Taking into account that fluid penetration caused corrosion on both boards, it cannot be excluded that fluid entered also the pump head assembly and residues are blocking the motor and/or fluid damages on the board are preventing the electronics to control the motor and therefore it's not turning.Based on gathered information, the most likely root cause of reported issue has been assigned to fluid penetration into the pump, most likely due to improper user maintenance over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: S5 MAST ROLLER PUMP
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 21604246
• Report Number: 9611109-2025-00104
• Device Sequence Number: 9601881
• Product Code: DTQ
• UDI-Device Identifier: 04033817900481
• UDI-Public: (01)04033817900481(11)170515
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103762
• 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
• Remedial Action: Other
• Type of Report: Initial,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: 10-88-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2017
• 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