BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVO

    MDR report key: 22345988 · Received June 27, 2025

    Report

    Report Number
    9611109-2025-90214
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 2, 2025
    Report Date
    December 16, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWF
    PMA / PMN Number
    K082344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE EVO. THE INCIDENT OCCURRED IN PORTUGAL. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION: FUNCTIONAL TEST DID NOT CONFIRM THE REPORTED ISSUE. LIVANOVA IS AWAITING FOR CUSTOMER APPROVAL TO PROCEED WITH THE PREVENTIVE REPLACEMENT OF THE ENCODER BOARD AND FLAT RIBBON CABLE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: AS A PRECAUTIONARY MEASURE, LIVANOVA TSSI REPRESENTATIVE REPLACED THE ENCODER BOARD ENC 0601 (PART NUMBER 90-305-910) AND THE FLAT RIBBON CABLE (PART NUMBER 97-101-871). A REVIEW OF THE DEVICE¿S SERVICE HISTORY INDICATED THAT THE EVO CLAMP WAS MANUFACTURED IN 2010 AND THAT NO PREVIOUS REPORTS OF SIMILAR EVENTS HAVE BEEN COMMUNICATED TO LIVANOVA. SINCE THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING INTERNAL TESTING, IT IS REASONABLE TO ASSUME THAT THE EVENT WAS NON-SYSTEMATIC; BASED ON INVESTIGATIONS OF SIMILAR CASES, IT CANNOT BE EXCLUDED THAT THE ERROR WAS CAUSED BY AN INTERMITTENT OR TEMPORARY ELECTRICAL FAULT BETWEEN THE ENCODER BOARD AND THE FLAT RIBBON CABLE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN EVO UNIT GAVE AN INTERMITTENT ERROR MESSAGE (1538 CODE) ASSOCIATED TO A FAULTY ENCODER. PINPOINT AND CLEAR OF THE NVMEM (NON-VOLATILE MEMORY) CALIBRATION PROCEDURES HAVE BEEN CARRIED OUT BY THE CUSTOMER; THE UNIT WORKED FOR A SHORT TIME THEN THE ERROR MESSAGE CAME BACK. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002860 EVO CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA DEUTSCHLAND ELCTRNC VENOUS OCCLDR UNIT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown