BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENZ

    MDR report key: 20558202 · Received October 29, 2024

    Report

    Report Number
    9611109-2024-00504
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 28, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817903062
    PMA / PMN Number
    K232291
    Removal / Correction Number
    Z-0571-2025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H 11: ANALYSIS OF THE COMPLAINT DATABASE REVEALED SIMILAR REPORTS FROM OTHER CUSTOMERS USING SW HLM.1.5. A SOFTWARE ANOMALY (PLN-43440) 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 SW HLM.1.5.1. LIVANOVA HAS TAKEN ACTION BY IMPLEMENTING A DEDICATED CAPA (CA-0016) AND A FIELD ACTION (FA-CP-MUN-2024-004 - Z-0571-2025) TO PROVIDE CUSTOMERS WITH INSTRUCTIONS ON IMMEDIATE MEASURES AND TO OUTLINE THE CORRECTIVE ACTIONS BEING IMPLEMENTED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE ESSENZ CONSOLE. THE INCIDENT OCCURRED IN ATLANTA, GEORGIA. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. RETRIEVED LOG AND CONFIGURATION FILES TO BE ANALYZED. THIS EVENT HAS BEEN CONSERVATIVELY REPORTED TO FDA, DESPITE LIVANOVA'S RISK ANALYSIS ASSESSING THE OVERALL RISK AS LOW AND WITHIN ACCEPTABLE LIMITS. LIVANOVA INITIATED AN INVESTIGATION. LIVANOVA IS RELEASING A CUSTOMER COMMUNICATION AS PART OF RECALL ACTION AND DEDICATED FDA 806 FORM WILL BE SUBMITTED SHORTLY. DEDICATED FOLLOW-UP REPORT WILL BE SUBMITTED REPORTING THE RECALL REFERENCE WHEN AVAILABLE.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A COCKPIT RESET OF AN ESSENZ CONSOLE EQUIPPED WITH SOFTWARE VERSION 1.5 OCCURRED DURING DEMO TRAINING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928901 ESSENZ CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 49-00-10 04033817903062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown