BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAEDIATRIC CANNULA, VENOUS

    MDR report key: 17078926 · Received June 7, 2023

    Report

    Report Number
    9680841-2023-00023
    Event Type
    Malfunction
    Date Received
    June 7, 2023
    Date of Event
    May 10, 2023
    Report Date
    August 29, 2023
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    UDI-DI
    08033178006156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED PAEDIATRIC CANNULA, VENOUS (CATALOG NUMBER V900-144) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE CANNULA ITEM V132-16 IS SIMILAR TO THE PAEDIATRIC CANNULA, VENOUS V900-144, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). G.5. THE PRODUCT ITEM V900-144 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE ITEM V132-16, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K890980 ). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED PRODUCT. H.10. SORIN GROUP ITALIA MANUFACTURES THE PAEDIATRIC CANNULA, VENOUS (CATALOG NUMBER V900-144). THE INCIDENT OCCURRED IN UNITED KINGDOM. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. ACCORDING TO FOLLOW UP WITH THE CUSTOMER, THE CANNULA WAS CLAMPED WITH THE SAME INSTRUMENT AS USUAL AS WELL AS WAS USED AS USUAL. THE BROKEN PART WAS NOTICED ON UNCLAMPING POST BYPASS IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DHR REVIEW HIGHLIGHTED THAT THE INVOLVED LOT WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. THE REVIEW OF THE COMPLAINTS DATABASE DID NOT IDENTIFY SIMILAR EVENTS ON THIS CANNULA CODE IN THE LAST 2 YEARS AND ON THE IMPACTED BATCH. THUS, THE CASE CAN BE CONSIDERED AS AN ISOLATED EVENT AND A SYSTEMATIC DEVIATION OF THE MANUFACTURING PROCESS CAN BE RULED OUT. THE RETURNED UNIT WAS INSPECTED AND MEASURED ACCORDING TO THE PROCEDURE USED IN THE PRODUCTION LINE, WHERE UNITS ARE 100 % CONTROLLED BEFORE RELEASE, AND WAS FOUND TO BE CONFORM TO SPECIFICATION. UNIT WAS CHECKED WITH PRODUCTION SPECIALISTS AND QUALITY ENGINEERS AND NO DEFECTS OR DEVIATIONS WERE IDENTIFIED THAT COULD EXPLAIN THE REPORTED FRACTURE. BASED ON ABOVE, THE REPORTED EVENT HAS BEEN REASONABLY TRACED BACK TO AN OCCASIONAL DEVIATION, AS A CONSEQUENCE OF ACCIDENTAL MECHANICAL STRESSES / ROUGH HANDLING DURING THE USE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED A REPORT THAT PEDIATRIC CANNULA BROKE AFTER THE PROCEDURE WAS COMPLETED. 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
    955942 PAEDIATRIC CANNULA, VENOUS CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP ITALIA 2111190009 08033178006156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown