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

Model Number	10-95-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that an essenz roller pump 85, used as blood cardioplegia (cpl-b) one, was defective during procedure.There was no patient injury.
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 munich, germany.Through follow-up communication livanova learned that the issue is apparently sporadic and occurs every now and then.To solve the issue, a loaner roller pump 85 has been installed as cardioplegia blood by a livanova field service representative.Subsequent functional verification testing was completed without issues and the unit was released to the customer.The cockpit logs were provided and analyzed.The analysis confirmed that the error message cu cpl-b defect was associated with the error code 4462, making the user aware of the issue.It is also reported that the pump can be controllable by means the ccu2 in the backup control panel.The 4462 error code indicates that the ccu2 ( associated with the cpl-b pump) was temporarily lost for 7 seconds.However, considering that the pump was still controllable and that issue never reoccurred aftwerwards, it cannot be ruled out that the most likely root causes was a false alarm coming from cockpit (wrong monitoring of cu can messages leading to wrong assumption on missing cu).Complaints database analysis revealed no similar event since unit installation in 2023 and no adverse and concerning trends about the reported failure mode have been triggered by periodical complaints statistical analysis.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: ESSENZ
• 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 80939 ; GM 80939
• Manufacturer Contact: antonella donatiello ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22588365
• Report Number: 9611109-2025-00131
• Device Sequence Number: 21180313
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)240612
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/21/2025

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: 10-95-00
• 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: 06/25/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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