BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    MDR report key: 16563357 · Received March 17, 2023

    Report

    Report Number
    9680841-2023-00007
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    February 16, 2023
    Report Date
    June 27, 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

    PATIENT INFORMATION WAS NOT PROVIDED. 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 PUMP ITEM 050300700J IS SIMILAR TO THE REVOLUTION PUMP ITEM 050300700 WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE COMPLAINED REVOLUTION CENTRIFUGAL BLOOD PUMP (CATALOG NUMBER 050300700J) IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE REVOLUTION PUMP ITEM 050300700 WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K190650). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED REVOLUTION PUMP. SORIN GROUP ITALIA MANUFACTURES THE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING. THE INCIDENT OCCURRED IN JAPAN. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA 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

    THROUGH FOLLOW UP WITH THE CUSTOMER, LIVANOVA LEARNED THE REVOLUTION PUMP AND TUBE WERE CONTINUED USE WITHOUT REPLACING. AT THE TIME OF LEAKAGE, THE USER ONCE STOPPED THE CIRCULATION, CLAMPED THE TUBE COMING FROM THE RESERVOIR, CONNECTED IT TO THE REV PUMP AGAIN, LETTING THE AIR OUT, AND RESTARTED THE CIRCULATION. THE CASE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS UNAFFECTED. THE LOT NUMBER OF THE REVOLUTION PUMP REMAINS UNKNOWN. IT IS UNKNOWN HOW THE REVOLUTION WAS INSTALLED BY THE CUSTOMER AND INSIGHTS REGARDING ALL DISPOSABLE SET UP. THE CUSTOMER SAID IS THAT IT MIGHT HAVE BEEN CAUSED BY THEIR FAULT AND THEY DID NOT SUSPECT ANY FAILURE IN THE DEVICE.

    Additional Manufacturer Narrative · 0

    INVOLVED UNIT WAS RECEIVED AT LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION OF THE INLET CONNECTOR FOUND NO DEFECT NOR DEVIATION. DIMENSIONAL ANALYSIS OF THE INLET AND OUTLET CONNECTOR DIAMETERS FOUND BOTH CONNECTOR DIAMITER SIZES WERE WITHIN SPECIFICATION. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE REGARDING INVOLVED LOTS OF UPPER LID AND REVOLUTION BASE PUMP. NO EVENTS HAVE BEEN REPORTED FOR INVOLVED FINISHED PRODUCT AND BASE PUMP LOTS. BASED ON ABOVE FACTS, NO PRODUCT DEVIATION WAS FOUND; IT CANNOT BE RULED OUT THAT REPORTED EVENT WAS DUE TO INCORRECT TUBE CONNECTION MADE BY CUSTOMER. 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, DURING A PROCEDURE, THE TUBE AT THE INLET PORT OF THE REVOLUTION PUMP DISCONNECTED AND CAUSED BLOOD LEAK. ACCORDING TO CUSTOMER, THE CONNECTION MAY NOT HAVE BEEN MADE PROPERLY. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664645 REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 050300700J 2212140014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown