BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    MDR report key: 13820223 · Received March 19, 2022

    Report

    Report Number
    9680841-2022-00016
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 20, 2023
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED CENTRIFUGAL PUMP REVOLUTION 5 (CATALOG NUMBER 050537CN, LOT 2106180122) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE CENTRIFUGAL PUMP REVOLUTION 5 ITEM 050537CN IS SIMILAR TO THE REVOLUTION CENTRIFUGAL BLOOD PUMP ITEM 050300700, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). DEVICE NOT AVAILABLE FOR INVESTIGATION. THE PRODUCT ITEM 050537CN IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE 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 (B)(4) MANUFACTURES THE COMPLAINED CENTRIFUGAL PUMP REVOLUTION 5 (CATALOG NUMBER 050537CN). THE INCIDENT OCCURRED IN (B)(6). ON FEBRUARY 22ND, 2022, DURING FOLLOW-UP WITH THE CUSTOMER, LIVANOVA HAS BEEN INFORMED THAT: TARGETED BLOOD FLOW BEFORE AND AFTER CHANGE-OUT WAS 5.5L/MIN. PRESSURE OF REVOLUTION PUMP AND OXYGENATOR WAS NOT MONITORED BEFORE AND AFTER CHANGE-OUT, ACT VALUE DURING THE ENTIRE ECMO PROCEDURE WAS 160-180S. NO BLOOD FLOW DECREASES, NOR DEVICE CHATTERING WAS OBSERVED. AFTER CHANGE-OUT, THE PATIENT'S HEMOGLOBIN INCREASED, HEMOLYSIS RELIEVED, PLATELET INCREASED, HEMOLYSIS URINATION IMPROVED. ECMO SUPPORT WAS FROM (B)(6) 2022. PATIENT IS NO LONGER IN ECMO. THE ISSUE WAS FOUND ON (B)(6), AND PUMP REPLACED ON (B)(6) 2022. CANNULAE HAVE NOT BEEN REPOSITIONED NOR CHANGED. NO CLOT WAS SEEN, AND NO DRUG WAS ADMINISTERED TO THE PATIENT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    FOLLOWING A REVIEW REVOLUTION EVENTS, THE OVERALL CONSIDERATION AS FOR PATIENT HEMOLYSIS WAS UPDATED TAKING INTO ACCOUNT THAT HEMOLYSIS IS A KNOWN RISK WHILE USING A CENTRIFUGAL PUMPS AND ALSO PATIENT CONDITION CAN BE THE REASON OF THE HEMOLYSIS. THE EVENT OCCURRED AT THE FIFTH DAY OF ECMO. ON THE BASIS OF THE RECEIVED ADDITIONAL INFORMATION, IT WAS STATED THAT THE PUMP WAS USED BEYOND THE MAX FLOW RATE INDICATED BY THE IFU (DECLARED 5.5 LPM INSTEAD OF 5 LPM AS INDICATED AS MAX FLOW RATE BY THE IFU). THEREFORE, THE EVENT IS LIKELY TO BE CAUSED BY USING THE PUMP EXCEEDING THE MAX FLOW RATE PRESCRIBED BY THE IFU. BASED ON COLLECTED EVIDENCES, THE EVENT WAS DUE TO THE USE CONDITIONS NOT COMPLIANT TO WHAT PRESCRIBED BY THE IFU.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS NOT MADE AVAILABLE FOR RETURN. HOWEVER, EXPLICATIVE PICTURES OF THE COMPLAINED PUMP WERE PROVIDED BY THE CUSTOMER AT THE SUBMISSION OF THE CASE. PICTURES SHOW THE UPPER WHITE HUB OF THE PUMP IS DAMAGED. THE ANALYSIS OF THE LIVANOVA COMPLAINTS DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR COMPLAINT RELATED TO THE INVOLVED REVOLUTION LOT. ACCORDINGLY, 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. BASED ON THE COLLECTED INFORMATION, THE REPORTED NOISE DURING THE PROCEDURE WAS DUE TO A DAMAGE OF THE REVOLUTION UPPER HUB RELATED TO PRESENCE OF POSSIBLE BLOOD CLOT AND/OR DEVICE MECHANICAL ISSUE. THE CAPA-MIR-2016-0007 HAS BEEN ISSUED TO ADDRESS THE DAMAGE OF THE WHITE UPPER HUB OF REVOLUTION PUMPS DURING ECMO PROCEDURES. AS FOR PATIENT HEMOLYSIS , IT SHALL BE NOTICED THAT HEMOLYSIS IS A KNOWN RISK WHILE USING A CENTRIFUGAL PUMPS. A DEVICE CONTRIBUTION IN THE REPORTED HEMOLYSIS CANNOT BE RULED OUT. HOWEVER, ALSO PATIENT CONDITION CAN BE THE REASON OF THE HEMOLYSIS. THE RISK IS IN THE ACCEPTABLE REGION. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT, THE FIFTH DAY OF THE ECMO SUPPORT, AN ABNORMAL NOISE AND BURNING MARKS WERE IDENTIFIED IN THE REVOLUTION5 PUMP. MEDICAL TEAM ELECTED TO CHANGE-OUT THE REVOUTION5 PUMP.

    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
    2222054 REVOLUTION CENTRIFUGAL BLOOD PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM SORIN GROUP ITALIA SRL 2106180122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown