BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

    MDR report key: 20652322 · Received November 11, 2024

    Report

    Report Number
    9680841-2024-00030
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 13, 2024
    Report Date
    December 10, 2024
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE REVOLUTION CENTRIFUGAL BLOOD PUMP COATED IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM IN01600, LOT 2606260070) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE PUMP WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP COATED IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE REVOLUTION PUMP (CATALOG NUMBER 050300700) IS REGISTERED IN THE USA (510(K) NUMBER: K190650). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE PUMP WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP COATED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H 11: THROUGH FOLLOW UP, IT WAS CLARIFIED THE CHANGE OUT OF THE REVOLUTION OCCURRED WHEN PERFUSION HAD JUST STARTED, MEDICAL TEAM ELECTED TO GO OFF PERFUSION, REPLACE THE PUMP AND GO BACK ON PERFUSION. SINCE THE CHANGE OUT OCCURRED PRIOR TO CROSS CLAMP APPLICATION, THE EVENT IS BEING REASSESSED AS NOT REPORTABLE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALY HAS RECEIVED A REPORT RELATED TO A LEAKAGE FROM THE REVOLUTION PUMP HEAD DURING PROCEDURE. THE PERFUSIONIST CHANGED OUT THE REVOLUTION PUMP WITH A NEW ONE. NO ADDITIONAL INFORMATION REGARDING CHANGE OUT DURATION AND PHASE (IF DURING CROSS-CLAMP OR NOT) IN WHICH THE CHANGE OUT OCCURRED, IS AVAILABLE SO FAR. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796312 REVOLUTION CENTRIFUGAL BLOOD PUMP COATED PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA 436980667PTS 2406180029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown