BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENZ

    MDR report key: 20620341 · Received November 6, 2024

    Report

    Report Number
    9611109-2024-00526
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 5, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817903062
    PMA / PMN Number
    K232291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE ESSENZ CONSOLE. THE INCIDENT OCCURRED IN MUENCHEN, GERMANY. 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.

    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 PROCEDURE. IN DETAIL, COCKPIT TURNED BLACK AND RESTARTED AGAIN AFTER ABOUT 30 SECONDS. SIMULTANEOUS FAILURE OF THE ELECTRONIC GAS BLENDER OCCURRED. THE GAS BLENDER WAS THEN SWITCHED ON MANUALLY AND THE PATIENT WAS SUPPLIED AGAIN. WHEN SWITCHED ON, THE GAS BLENDER WENT BACK TO SETTING OF 21 OF FIO2%. THERE WERE NO COMPLICATIONS DURING THE REST OF THE SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460158 ESSENZ CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND HLM 04033817903062

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown