BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIDS OXYGENATOR D101

    MDR report key: 21772193 · Received April 4, 2025

    Report

    Report Number
    9680841-2025-900002
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 30, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. THE KIDS D101 OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (C20446ND) 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. G.5. THE COMPLAINED KIDS D101 OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE OXYGENATOR (CATALOG NUMBER 050595) IS REGISTERED IN THE USA (510(K) NUMBER: K231652). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE KIDS D101 OXYGENATOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP, LIVANOVA WAS INFORMED THE LOWEST ARTERIAL PO2 VALUE MEASURED IN THE FIRST PROCEDURE WAS 17 KPA (127 MMHG) AT 90% OF FIO2 AND 3 LPM OXYGEN FLOW AND THE LOWEST ARTERIAL PO2 VALUE MEASURED IN THE SECOND PROCEDURE WAS 15 KPA (112 MMHG) AT 100% OD FIO2 AND 4 LPM OXYGEN FLOW. BOTH THE LOW OXYGENATION CONDITIONS LASTED MORE THAN 3 MINUTES, HOWEVER NO CHANGE OUT OF THE OXYGENATORS WAS PERFORMED AND NO NEGATIVE CONSEQUENCES TO THE PATIENTS WERE CAUSED. ACCORDING TO LIVANOVA EVALUTATION, IN BOTH EVENT, THE PAO2 WAS SUFFICIENT TO MAINTAIN THE TISSUE BUFFER FUNCTION OF HEMOGLOBIN. ADDITIONALLY, IT IS POSSIBLE TO ASSESS THAT THE OXYGEN REQUEST OF TISSUES DURING CPB IS LOWER THAN THE OXYGEN NEEDS TO SUPPORT BASAL METABOLISM. SINCE THERE WAS NO PATIENT IMPACT, THERE WAS NO MEDICAL INTERVENTIONS OTHER THAN THOSE REPORTED WITHIN PRODUCT IFU AND THE PAO2 WAS NOT BELOW DETERMINED VALUES, THE EVENT IS BEING REASSESSED AS NOT REPORTABLE. THE LIKELIHOOD OF OCCURRENCE OF THE FAILURE IS IN LINE WITH WHAT DOCUMENTED AND ACCEPTED IN THE RELEVANT RISK MANAGEMENT FILE. THE RISK IS IN THE ACCEPTABLE REGION.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT IN TWO (2) PROCEDURE THE D101 OXYGENATORS DID NOT PROVIDE ADEQUATE OXYGEN EXCHANGE. THIS WAS PARTICULARLY NOTICEABLE DUE TO THE HIGH FIO2 LEVELS REQUIRED, NAMELY 90-91%. ESPECIALLY THE SECOND PROCEDURE WAS NOT EXPLAINABLE BY OTHER CLINICAL CIRCUMSTANCES.THERE IS NO REPORT OF ANY PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632395 KIDS OXYGENATOR D101 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA SRL D101 DIDECO KIDS PH SUB ND 2406050027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown