BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 DOUBLE ROLLER PUMP 85

    MDR report key: 23039390 · Received September 12, 2025

    Report

    Report Number
    9611109-2025-90358
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 13, 2025
    Report Date
    March 18, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K071318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: COMPLAINTS DATABASE REVIEW REVEALED NO FURTHER SIMILAR EVENTS SINCE UNIT¿S INSTALLATION. NO CONCERNING TREND WAS HIGHLIGHTED FOR REPORTED FAILURE MODE. BASED ON THE INVESTIGATION FINDINGS, CONSIDERING THAT THE ISSUE WAS NOT SYSTEMATIC AND WAS NOT REPRODUCED, THE ROOT CAUSE OF THE EVENT WAS ADDRESSED TO A TEMPORARY COMMUNICATION ERROR BETWEEN THE HKR PROCESSOR BOARD AND THE SHAFT ANGLE ENCODER. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4 UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS NOT AVAILABLE FOR THIS PRODUCT AS IT IS A CLASS II MEDICAL DEVICE MANUFACTURED BEFORE SEPTEMBER 24, 2016 WHICH IS THE FDA COMPLIANCE DATE TO IMPLEMENT UDI CODE. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 DOUBLE ROLLER PUMP 85. THE INCIDENT OCCURRED IN UK. A LIVANOVA FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE FACILITY FOR INVESTIGATION AND COULD NOT CONFIRM THE REPORTED ISSUE. CUSTOMER SHOWED TO FSE PHOTOGRAPHIC EVIDENCE OF THE FAILURE. THUS, FSE REPLACED BOTH ROTARY ENCODER AND HKR BOARD AS PRECAUTION. FOLLOWING TESTING OF THE UNIT PASSED SUCCESSFULLY. 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 OF A 'SHAFT ANGLE ENCODER' ERROR DISPLAYED ONTO S5 DOUBLE ROLLER PUMP 85. THE EVENT OCCURRED AFTER THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026038 S5 DOUBLE ROLLER PUMP 85 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ LIVANOVA DEUTSCHLAND DRP 85

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown