BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

    MDR report key: 22291562 · Received June 19, 2025

    Report

    Report Number
    9680841-2025-900012
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 20, 2025
    Report Date
    September 26, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1., A.5. THERE WAS NO PATIENT INVOLVEMENT D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED REVOLUTION PUMP (CATALOG NUMBER 050300700J) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE PUMP ITEM 050300700J IS SIMILAR TO THE PUMP 050300700, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM 050300700J IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO THE PUMP 050300700, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K190650). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED PUMP. H.11. SORIN GROUP ITALIA MANUFACTURES THE REVOLUTION PUMP. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    PICTURE OF THE FOREIGN MATTER WAS PROVIDED, HOWEVER SINCE THE NATURE OF THE PARTICLE COULD NOT BE DEFINED, THE DEVICE WAS REQUESTED BACK FOR INVESTIGATION. VISUAL INSPECTION OF RETURNED UNIT CONFIRMED THE PRESENCE OF A BLACK SPOT, MOST LIKELY A MOULDING BURN, EMBEDDED IN THE REVOLUTION CASE. REVIEW OF LIVANOVA COMPLAINTS DATABASE IDENTIFIED NO FURTHER SIMILAR CASES NOTIFIED FOR CONCERNED BATCH, THUS A SYSTEMATIC QUALITY ISSUE CAN BE EXCLUDED. NO ADVERSE TREND RELATED TO THIS ISSUE HAS BEEN IDENTIFIED EITHER. BASED ON VISUAL INSPECTION RESULTS, REPORTED FAILURE HAS BEEN ASSIGNED TO ACCIDENTAL MOULDING DEVIATION OCCURRED IN MANUFACTURING LINE, ESCAPING FINAL VISUAL CONTROLS BEFORE PRODUCT RELEASE. SINCE THE ISSUE IS A COSMETIC DEVIATION, THE EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH, EVEN IF RE-OCCURRED. THEREFORE, THE EVENT HAS BEEN 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 ITALIA HAS RECEIVED A REPORT THAT, DURING PRIMING, FOREIGN MATTER WAS FOUND IN THE REVOLUTION PUMP. DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864757 REVOLUTION CENTRIFUGAL BLOOD PUMP COATED PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL REVOLUTION PUMPHEAD 2411260030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown