BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE ROLLER PUMP 85

    MDR report key: 16204963 · Received January 19, 2023

    Report

    Report Number
    9611109-2023-00030
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 19, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWB
    UDI-DI
    04033817900405
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2015. IT CANNOT BE EXCLUDED THAT AN ELECTRICAL/ELECTRONIC DEVIATION OF THE REPLACED COMPONENTS (BOARDS) WAS THE ROOT CAUSE OF THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THERE WAS NOT PATIENT INVOLVEMENT. LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 DOUBLE ROLLER PUMP 85. THE INCIDENT OCCURRED IN ITALY. THE READ-OUT OF THE PUMP WAS EXECUTED. BOARDS HMF (MOTOR END STAGE BOARD) AND HMS (MOTOR CONTROL BOARD) HAVE BEEN REPLACED. FUNCTIONAL TEST PERFORMED AND UNIT RETURNED TO CUSTOMER 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 DOUBLE HEAD PUMP SHOWED FAULT IN MOTOR CONTROLLER ERROR (E429) DURING PRIMING FOR PUMP HEAD B. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363953 S5 DOUBLE ROLLER PUMP 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DWB LIVANOVA DEUTSCHLAND 10-85-00 04033817900405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown