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

Model Number	COCKPIT
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the essenz cockpit.The incident occurred in (b)(6), netherlands.This event has been conservatively reported to fda, despite livanova's risk analysis assessing the overall risk as low and within acceptable limits.The cockpit log files have been requested and analysed.A touch screen controller processor (tscp) failure has been logged in the date of event.A software anomaly has been logged to address the reported issue.The investigation confirmed the problem, highlighting that the backup control unit maintains control during the reset.Once the cockpit user interface is restored, the ¿last case¿ button enables users to retrieve all prior settings and proceed without any data loss.During the reset, the heart-lung machine's critical functions, including pumps, alarms, sensors, and safety systems, continued to perform as designed.In certain scenarios, the gas blender might switch to standby mode, requiring the operator to reactivate it via the user interface on the gas blender unit to ensure continuous operation.After a second reset, a new case must be initiated from the home screen.The root cause of this issue was identified as a software anomaly related to a memory violation.The issue has been fixed under hlm software upgrade version 1.5.1.Livanova has taken action by implementing a dedicated capa (ca-0016).In addition, livanova released a customer communication as part of recall action and dedicated fda 806 form has been submitted on 31st october 2024.
Event or Problem Description
Livanova deutschland received a report that a cockpit reset of an essenz console equipped with software version 1.5 occurred during procedure.Perfusionist saw the sao2 and po2 dropped during reboot.After pushing the button "last case" the cockpit was working again normally.Procedure was completed without further issues.There was no patient injury.

• 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: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20693056
• Report Number: 9611109-2024-00549
• Device Sequence Number: 8584897
• Product Code: DTQ
• UDI-Device Identifier: 04033817903048
• UDI-Public: (01)04033817903048(11)230213
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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: COCKPIT
• Device Catalogue Number: 28-97-10
• 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: 10/17/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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