BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 15903525 · Received December 2, 2022

    Report

    Report Number
    9680841-2022-00056
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 4, 2022
    Report Date
    August 28, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700J) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700J) IS SIMILAR TO THE REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700), WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS 08033178104791. G.5. THE THE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700J) IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE ITHE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K190650). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED PUMP. SORIN GROUP ITALIA MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP. THE INCIDENT OCCURRED (B)(6). AS PER FOLLOW UP WITH THE CUSTOMER: - DURING PROCEDURE, THE BLOOD FLOW HAS UNINTENTIONALLY BEEN INTERRUPTED. - THE DECAY IN THE PRESSURE DROP WAS MEASURED BOTH AT THE INLET AND AT THE OUTLET OF THE OXYGENATOR (MANUFACTURED BY A COMPETITOR). - AS TROUBLESHOOTING ACTIVITY, THE MAXIMUM RPM'S OF THE PUMP SET BY PERFUSIONIST WERE ABOUT 3200, WHICH GENERATED A TOTAL BLOOD FLOW OF 2 LPM. - ONLY THE REVOLUTION PUMP WAS CHANGED-OUT. THE OTHER COMPONENTS OF THE CIRCUIT WERE NOT REPLACED. - UNIT IS AVAILABLE AND WILL BE RETURNED TO LIVANOVA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    REVIEW OF LIVANOVA COMPLAINTS DATABASE REVEALED NO OTHER SIMILAR ISSUE NOTIFIED FOR BATCH CONCERNED FROM THE MARKET. VERIFICATION OF MANUFACTURING RECORDS CONFIRMED THAT NOTICED UNIT WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. VISUAL INSPECTION OF RETURNED PUMP DID NOT HIGHLIGHT ANY DAMAGE TO THE WHITE UPPER BEARING. A SUBSEQUENT FUNCTIONAL TEST WITH BOVINE BLOOD DID NOT CONFIRM ANY DISCREPANCY IN MEASURED VALUES OF REVOLUTION IN-FLOW AND OUT-FLOW: PUMP WAS CAPABLE TO CONVEY BLOOD TO THE OXYGENATOR WITHOUT ANY PRESSURE DROP IDENTIFIED. BASED ON LABORATORY TEST RESULTS, AND CONSIDERING THE SURGERY CONDITIONS AND CIRCUIT SETTINGS AT THE TIME OF FAILURE, IT IS VERY LIKELY THAT REPORTED EVENT IS RELATED TO THE HYPERTENSION OF THE PATIENT AND SUBSEQUENT INCREASED LINE RESISTANCE. NO DEVIATION OF THE REVOLUTION PUMP FROM SPECIFICATIONS WAS ESTABLISHED. 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 ITALIA HAS RECEIVED A REPORT THAT, WHEN CPB STARTED, SHIFTING THE PATIENT TO HYPOTHERMIA, THE CIRCULATION FLOW WAS NOT PRODUCED DUE TO A DECREASE IN BOTH THE BLOOD PRESSURE RIGHT BEFORE THE OXYGENATOR AND THE TRANSMITTED BLOOD PRESSURE, EVEN IF THE ROTATION SPEED WAS INCREASED. THE SITUATION RECOVERED WHILE AN OPERATOR WAS CHECKING OTHER PART OF THE CIRCUIT. SINCE THE CAUSE WAS NOT CLEAR, THE PUMP WAS CHANGED OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403304 REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 2205020011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown