BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN S5 SYSTEM

    MDR report key: 16320410 · Received February 8, 2023

    Report

    Report Number
    9611109-2023-00051
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    February 8, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    UDI-DI
    04033817902676
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ERC TUBING CLAMP. THE INCIDENT OCCURRED IN GERMANY. LIVANOVA INITIATED AN INVESTIGATION. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE. THE CONTROL PANEL HKR CIRCUIT BOARD HAS BEEN CHECKED AND IT WAS FOUND THAT THE ISSUE WAS DUE TO A CONTACT PROBLEMS THAT WAS ELIMINATED, SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: DESPITE SEVERAL ATTEMPTS, THE SPECIFIC ERROR MESSAGE THAT APPEARED AT THE TIME OF EVENT COULD NOT BE RECOVERED. BASED ON INVESTIGATION RESULTS OF SIMILAR EVENTS, FOR WHICH THE REPLACEMENT OF HKR BOARD SOLVED THE ISSUE, IT IS REASONABLE TO ASSUME THAT THE ERROR MESSAGE WAS A "MOTOR CONTROL FAILURE". THEREFORE, MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT COULD BE TRACED BACK TO A DEFECTIVE HKR BOARD.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE CONTROL PANEL OF THE MAST PUMP ON THE HEART-LUNG MACHINE DISPLAYS AN ERROR MESSAGE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313867 SORIN S5 SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND 48-40-00Z 04033817902676

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown