BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION 5

    MDR report key: 22751320 · Received August 8, 2025

    Report

    Report Number
    9680841-2025-900021
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    June 27, 2025
    Report Date
    January 8, 2026
    Manufacturer
    MIRANDOLA
    Product Code
    KFM
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11. NO FURTHER INFORMATION WAS MADE AVAILABLE CONCERNING PATIENT CLINICAL CONSEQUENCES. THE DEVICE HISTORY RECORD REVIEW (DHR) WAS PERFORMED AND HIGHLIGHTED THAT THE INVOLVED LOT OF REVOLUTION WAS RELEASED AS CONFORMING ACCORDING TO SPECIFICATIONS. THE COMPLAINTS DATABASE REVIEW DID NOT IDENTIFY ANY CONCERNING TREND NOR FURTHER SIMILAR EVENTS THAT HAVE BEEN REPORTED FOR THIS LOT NUMBER. BASED ON INVESTIGATION FINDINGS, A MANUFACTURING DEVIATION WAS EXCLUDED AS ROOT CAUSE OF THE EVENT, WHILE THE REVOLUTION IMPELLER MOST LIKELY LIFTED UP AND APPLIED STRONG PRESSURE ON THE UPPER BEARING DUE TO EXCESSIVE NEGATIVE PRESSURE (BELOW 50 MMHG) APPLIED TO THE PUMP INLET. MOST LIKELY IT WENT UNDETECTED DUE TO LACK OF MONITORING OF THE INLET PRESSURE. IN THIS REGARD, PRODUCT'S INSTRUCTIONS FOR USE RECOMMEND MONITORING UPSTREAM AND DOWNSTREAM PUMP OPERATING PRESSURE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    H11: THE COMPLAINED DEVICE WAS INVESTIGATED AT MANUFACTURING SITE. VISUAL INSPECTION REVEALED THAT THE WHITE UPPER HUB WAS EXTREMELY DAMAGED, WITH THE SHAFT COMING OUT OF THE HUB. THE HUB WAS LIFTED DOWN, IN CONTACT WITH THE ROTOR. ADDITIONAL INFORMATION PROVIDED BY THE PERFUSIONIST INDICATED THAT LIVANOVA SCPC SYSTEM WAS IN USE AND THAT IT WAS CHECKED BY LIVANOVA FIELD SERVICE TECHNICIAN BEFORE AND AFTER THE EVENT, WITHOUT REPORTING ANY ISSUE. REPORTEDLY, PATIENT SUPPORT INITIATED ON (B)(6) AND WAS OVER ON (B)(6). THE ECMO SYSTEM OPERATED AT RPMS BETWEEN 1500 AND 2000 WITH NO PRESSURE ALARMS. A DROP IN BLOOD FLOW WAS OBSERVED DURING USE. A PURGE WAS PERFORMED, AND NO CLOT WAS FOUND. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    D.4. THE CENTRIFUGAL PUMP REVOLUTION 5 IS A NON-STERILE DEVICE, ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE NUMBER C21168ND, LOT 2409120053), 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 CENTRIFUGAL PUMP REVOLUTION 5 IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE 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.10. LIVANOVA MANUFACTURES THE CENTRIFUGAL PUMP REVOLUTION 5. THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, AFTER A SCHEDULED ECMO CIRCUIT CHANGE PERFORMED AT 4:00 PM, THE PUMP MADE A NOISE AND STOPPED AT 6:40 PM. IT WAS NECESSARY TO INSERT THE PUMP HEAD ONTO THE EMERGENCY MANUAL CRANK TO MAINTAIN FLOW AND THEREFORE BLOOD CIRCULATION. DESPITE MAINTAINING THE FLOW MANUALLY, THE PUMP HEAD BECAME STUCK, CAUSING IT TO STOP FOR A FEW SECONDS, A TOTAL OF 10 TIMES. THIS MANUAL HANDOVER LASTED 1.5 HOURS, ALLOWING THE OPERATING ROOM TEAM (SURGEONS, RESIDENTS, PERFUSIONISTS, AND IBODES) TO ARRIVE AT THE PATIENT'S BEDSIDE AND BE READY FOR ANOTHER CHANGE OF THE EXTRACORPOREAL CIRCUIT. CLINICAL CONSEQUENCES AND CURRENT CONDITION OF THE PATIENT: - PROBABLE INADEQUATE CIRCULATORY SUPPORT FLOW OVER A PROLONGED PERIOD (>1 HOUR). - SIGNIFICANT HEMODYNAMIC AND RESPIRATORY INSTABILITY. - MULTIPLE TRANSFUSIONS. ACTIONS TAKEN FOR THE PATIENT REGARDING THE DEVICE: ECMO CIRCUIT CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223406 REVOLUTION 5 PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MIRANDOLA POMPA CENTRIFUGA REV. 5 SUB 2409040075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other