MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ESSENZ; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	RP85
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz roller pump 85.The incident occurred in london, united kingdom.The serial read-out of the involved pump (real time device parameters and setting recording file) was extracted and analyzed.In the date of the event, error code 2353 was recorded.Error code 2353 indicates that a safety measure in the control unit is defective.The issue is most likely associated with a faulty of the motor head (hall sensor) or motor control board (hms).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 an essenz roller pump 85, used as suction pump, gave the following error message: "suction 3 pump issue (replace suction 3 pump after case)" during procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: complaints database review revealed no further similar issues reported for involved unit.No concerning trend was detected for the reported failure mode.Based on available evidence, the event root cause could be traced back to an isolated event of temporary communication issue with the pump resolver on the hms motor control board.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: ESSENZ
• 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: 22561607
• Report Number: 9611109-2025-90261
• Device Sequence Number: 11760853
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)240812
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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