MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	RP85
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the roller pump.Through follow up, it was clarified the pump did not run and no error message was displayed on the cockpit.The issue was solved by turning the hlm off and back on.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 the roller pump 85 was primed fine.However, when switched to bypass mode, the roller pump (user as cpl blood pump) did not work.Medical team power cycled the essenz hlm and it worked.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: as per available information, no field service activity was deemed necessary by the customer.Complaints database analysis revealed no similar event since unit installation in 2024.No concerning trends about the reported failure was highlighted.Considering that issue was solved by switching off and then back on the device, the event was considered as isolated due to a temporary failure, whose root causes could be traced back to one of the following: - a transient communication issue between the cockpit and the pump module, resulting in an improper data transmission between the two and consequently providing an inconsistent state value of the pump itself; - a communication timeout or can bus interruption; - an electrical issue related to power supply fluctuation; a brief voltage dip or unstable power during system start could cause the pump controller to hang without triggering an error code.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ROLLER PUMP 85
• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22084449
• Report Number: 9611109-2025-90140
• Device Sequence Number: 6935427
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)240424
• Combination Product (Y/N): N
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/24/2025

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: RP85
• Device Catalogue Number: 10-95-00
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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