BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 SYSTEM

    MDR report key: 15606583 · Received October 14, 2022

    Report

    Report Number
    9611109-2022-00523
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 14, 2022
    Report Date
    May 9, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    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

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 SYSTEM. THE INCIDENT OCCURRED IN AUGUSTA, GEORGIA. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT CUSTOMER REQUESTED PHONE SUPPORT AND THAT MAINTENANCE ON THE DEVICE IS HANDLED BY THE CUSTOMER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CUSTOMER SERVICES HIS OWN EQUIPMENT.

    Additional Manufacturer Narrative · 0

    THE REPORTED ERROR MESSAGE INDICATES THAT AN INTERNAL MALFUNCTION HAS OCCURRED AND POSSIBLE FAULT COULD BE THE RELATED TO THE MAIN PROCESSOR OF THE CIRCUIT BOARD HKR. ACCORDING TO THE COMPLAINTS DATABASE REVIEW NO OTHER SIMILAR ISSUES HAVE BEEN SUBMITTED FOR THIS UNIT SINCE ITS INSTALLATION IN 2014. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE WAS A FAULTY HKR BOARD. THE WEARING OF ELECTRO-MECHANICAL DEVICE CAN BE ORIGINATED BY THE SPECIFIC USE CONDITION AT CUSTOMER SITE AND MAY HAVE CONTRIBUTED TO THE EVENT. 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 RECEIVED REPORT THAT A "SHORT TERM INTERNAL MALFUNCTION " ERROR MESSAGE OCCURRED ON A PUMP USED ON A S5 SYSTEM DURING PROCEDURE. REPORTEDLY THE PUMP DID NOT STOP. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2600615 S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-40-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown