BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION PHISIO CENTRIFUGAL PUMP

    MDR report key: 12049592 · Received June 23, 2021

    Report

    Report Number
    9680841-2021-00016
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    October 28, 2021
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA HAS RECEIVED A REPORT OF FLOW STOP DURING AN ECMO PROCEDURE, USING A REVOLUTION PUMP. THE UNIT WAS NOT MADE AVAILABLE FOR RETURN. HOWEVER, TWO VIDEOS OF THE INVOLVED REVOLUTION PUMP WERE PROVIDED AND SHOWED A DAMAGE TO THE REVOLUTION PUMP UPPER BEARING. THE ANALYSIS OF THE COMPLAINTS DATABASE REVELED THAT NO FURTHER COMPLAINTS RELATED TO THE INVOLVED REVOLUTION LOT HAVE BEEN REPORTED. DHR VERIFICATION DID NOT REVEAL ANY RELEVANT INFORMATION POSSIBLY LINKED WITH THE CLAIMED DEFECT. THE DEVICE PASSED ALL RELEASE TESTS, INCLUDING SPIN TEST TO VERIFY CORRECT ROTATION, WITHOUT NON CONFORMITIES. BASED ON THE COLLECTED INFORMATION, LIVANOVA BELIEVES THE FLOW STOP WAS DUE TO A DAMAGE OF THE REVOLUTION UPPER HUB. TO FURTHER INVESTIGATE THE ROOT CAUSES OF THE DAMAGE OF THE WHITE UPPER HUB OF REVOLUTION PUMPS DURING USAGE IN ECMO THE CAPA-MIR-2016-0007 WAS ISSUED. THE RISK IS IN THE ACCEPTABLE REGION. NO FURTHER ACTION IS DEEMED NECESSARY. LIVANOVA WILL MAINTAIN MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. THE REVOLUTION CENTRIFUGAL PUMP IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (ITEM 086267, LOT 2103230018) THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. THE COMPLAINED REVOLUTION CENTRIFUGAL PUMP IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STANDALONE REVOLUTION CENTRIFUGAL PUMP (CATALOG NUMBER 050300700) IS REGISTERED IN THE USA (510(K) NUMBER: K190650). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE REVOLUTION CENTRIFUGAL PUMP. THE INCIDENT OCCURRED IN CALI VALLE DEL CAUCA, COLOMBIA. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    LIVANOVA HAS RECEIVED A REPORT THAT, AFTER 18 HOURS THE ECMO PROCEDURE, WHEN THE REVOLUTION PUMP WAS AT 3200RPM (4,8L/MIN) A LOUD SOUND WAS HEARD AND FLOW DROPPED. THE PATIENT HAD BEEN SUPPORTED WITH PHARMACOLOGY THERAPY AND HAND CRACK OF EMERGENCY FOR 30 MINUTES UNTIL THE PUMP WAS CHANGED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950086 REVOLUTION PHISIO CENTRIFUGAL PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 2103010024

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention