BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SYSTEM

    MDR report key: 22139553 · Received June 4, 2025

    Report

    Report Number
    9611109-2025-90162
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 6, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817900887
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN (B)(6). 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: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE ISSUE REMAINED EVEN WITH CHANGING ERC. THE REPORTED ISSUE COULD BE CONFIRMED. SERIAL READ-OUT WAS EXTRACTED FROM THE CP5 PANEL THAT WAS IN USE WITH THE AFFECTED ERC. IN ORDER TO SOLVE THE ISSUE, HEK/HEX BOARDS WERE REPLACED. SYSTEM SOFTWARE WAS RELOADED ON BUBBLE, LEVEL, CP5 AND SYSTEM BOARDS. AFTER SWAPPING HEK/HEX BOARDS, ERC WAS TESTED AND CONFIRMED THAT IT WAS DEFECTIVE. NO ISSUES OCCURRED AFTER ERC WAS SWAPPED WITH A REPLACEMENT UNIT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT AN ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) OF AN S5 SYSTEM GAVE AN ERROR MESSAGE DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587576 S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND SRD S5 CONSOLE FOR 3 PUMP 04033817900887

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown