MAUDE Adverse Event Report: LivaNova Deutschland Essenz Roller Pump; Console, Heart-Lung Machine, Cardiopulmonary Bypass

Model Number	RPD85
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that essenz hlm cpl-c pump displayed an error code indicating that the pump was not working properly (2335).Reportedly, the error could not be cleared despite powering down and rebooting the hlm system.The affected roller pump was then replaced with a loan unit.The event occurred during priming.There was no patient injury.
Additional Manufacturer Narrative
A1-a5 patient information was not provided.H11 livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: Essenz Roller Pump
• 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: 50814442
• Report Number: 9611109-2026-90434
• Device Sequence Number: 10680705
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)251124
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: RPD85
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 11/24/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown