BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIFUGAL PUMP REVOLUTION 5

    MDR report key: 17448313 · Received August 3, 2023

    Report

    Report Number
    9680841-2023-00033
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 9, 2023
    Report Date
    December 4, 2023
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED . D.4. THE CENTRIFUGAL PUMP REVOLUTION 5 IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK 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 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 SOUTH KOREA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, 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 PRODUCTION RECORDS SHOWED THAT COMPLAINED PUMP PASSED ALL RELEASE TESTS, INCLUDING SPIN TEST TO VERIFY CORRECT ROTATION, WITHOUT ANY DEVIATION. BASED ON THE ABOVE FACTS, REPORTED EVENT WAS TRACED BACK TO DAMAGED REVOLUTION UPPER HUB POSSIBLY RELATED TO THE PRESENCE OF BLOOD CLOTS AND/OR DEVICE MECHANICAL ISSUE LIVANOVA IS FURTHER INVESTIGATING THE ROOT CAUSE OF THE DAMAGE OF THE WHITE UPPER HUB OF REVOLUTION PUMPS DURING ECMO PROCEDURES. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET. THIS REPORT WAS DUE ON (B)(6) 2023; HOWEVER, DUE TO A NETWORK DISRUPTION AT LIVANOVA, THE ABILITY TO SUBMIT MDRS WAS LOST ON (B)(6) 2023, BEFORE THIS REPORT WAS READY TO SUBMIT. THE REPORT WAS PREPARED AND SUBMITTED IMMEDIATELY FOLLOWING RESTORATION OF THE LIVANOVA SYSTEMS.

    Additional Manufacturer Narrative · 0

    AS PER FOLLOW UP, THE CUSTOMER ALSO COMPLAINED ABOUT NO FLOW CONDITION. THE ISSUE OCCURRED NEARLY 36 HOURS AFTER ECMO STARTED, AND AFTER ABOUT 10 HOURS, THEY REPLACED IT WITH A COMPETITION ECMO EQUIPMENT. THEY DIDN'T MEASURE THE PUMP INLET PRESSURE INLET DURING CASE. THE PATIENT WAS NOT AFFECTED. 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

    SORIN GROPU ITALIA HAS RECEIVED A REPORT THAT, DURING ECMO SUPPORT, AS PER VIDEO PROVIDED, THE SPEED OF THE REVOLUTION PUMP WAS RAISED TO 3500 RPM AND NO FLOW WAS GENERATED. NOISE AND UPPER REVOLUTION BEARING WAS BLACK. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698680 CENTRIFUGAL PUMP REVOLUTION 5 PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA 03598 2203020010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown