BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 ROLLER PUMP

    MDR report key: 16937295 · Received May 16, 2023

    Report

    Report Number
    9611109-2023-00225
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 18, 2023
    Report Date
    May 15, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. IN ORDER TO SOLVE IT, COMPUTER BOARD (HKR), MOTOR CONTROL BOARD (HMS) WERE REPLACED. IN ADDITION, LCD/LED PANEL WITH TOUCH SCREEN, RIBBON CABLES, SILICONE GASKET AND CABLE SPEAKER WERE REPLACED AS PER S5 SYSTEM USER MANUAL SINCE THEY WERE THE OLD VERSION. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE REPORTED ERROR MESSAGE IS MOSTLY CAUSED BY AN INTERRUPTION OF THE CONNECTION BETWEEN HKR AND HMS BOARDS, MEANING THAT THE HMS BOARD DID NOT GET INFORMATION FROM THE HKR BOARD. COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2010. BASED ON THE INFORMATION AVAILABLE AND LIVANOVA TECHNICAL INTERVENTION, IT CANNOT BE RULED OUT THAT THE REPORTED EVENT WAS DUE TO AN ELECTRICAL FAILURE OF THE HKR BOARD OR HMS BOARD.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ROLLER PUMP. THE INCIDENT OCCURRED IN FAYETTEVILLE, ARKANSAS. LIVANOVA INITIATED AN INVESTIGATION. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A S5 ROLLER PUMP GAVE A MOTOR CONTROL FAILURE ERROR MESSAGE AT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467973 S5 ROLLER PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-80-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown