BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

    MDR report key: 23776508 · Received December 11, 2025

    Report

    Report Number
    9680841-2025-900037
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 14, 2025
    Report Date
    May 29, 2026
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    UDI-DI
    00803622157493
    PMA / PMN Number
    K190650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE REVOLUTION PC PUMP IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE UNIQUE IDENTIFIER (UDI) AND THE EXPIRATION DATE REFER TO THE STERILE FINISHED PRODUCT INTO WHICH THE DEVICE WAS ASSEMBLED. G.5. THE INVOLVED REVOLUTION PC PUMP IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE REVOLUTION PC (CATALOG NUMBER 050300700) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K190650). H.4. THE DEVICE MANUFACTURING DATE REFERS TO MANUFACTURING DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE REVOLUTION PUMP WAS ASSEMBLED. H11: THROUGH FOLLOW-UP COMMUNICATIONS, LIVANOVA LEARNED THAT THE REVOLUTION PUMP WAS PUT AT MAXIMUM RPMS AND THE TARGET FLOW WAS NOT REACHED. THE PRESSURE/FLOW ISSUE OCCURRED WITHIN ONE MINUTE AFTER THE PROCEDURE STARTED. NO BLOOD CLOT WAS NOTED IN THE CIRCUIT AND NO DAMAGE WAS OBSERVED ON THE COMPLAINED REVOLUTION PUMP. 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

    SORIN GROUP ITALIA RECEIVED A REPORT OF A REVOLUTION PUMP WHICH COULD NOT PROVIDE PROPER FLOW WHEN INCREASING ROUNDS PER MINUTES (RPMS), AND LOW PRESSURE WAS HIGHLIGHTED AT INLET PUMP LINE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494852 REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING) PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA REVOLUTION PC (PTS: 2523300006) 00803622157493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown