MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND 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	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that roller pump 85 displayed an alarm pump defective during a procedure.Medical team replaced the cardioplegia crystal pump.There is no report of any patient injury.Customer: (b)(6).
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H11: livanova deutschland manufactures the essenz roller pump.A livanova field service representative was dispatched to the facility to investigate the device.The defective pump error came up on the cpl-c pump.This is a known software problem.The complained pump was checked and the issue could not be duplicate.Serial read out (real time device parameters and setting recording file) of the pump was collected and has been investigated the log analysis was not successful since the files weren't pulled out correctly, so the error code associated to the "pump defective" message cannot be confirmed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
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.Based on the current level of information the root cause cannot be identified, however, it cannot be ruled out that the most likely root cause is related to sw exception not correctly handled by the control unit.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: ESSENZ
• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20578102
• Report Number: 9611109-2024-00517
• Device Sequence Number: 8003216
• Product Code: DTQ
• UDI-Device Identifier: 04033817903086
• UDI-Public: (01)04033817903086(11)230913
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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
• Device Model Number: 10-95-00
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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