BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D131 KIDS INFANT ARTERIAL FILTER

    MDR report key: 25232257 · Received May 20, 2026

    Report

    Report Number
    9680841-2026-900018
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 20, 2026
    Report Date
    May 20, 2026
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE D131 KIDS INFANT ARTERIAL FILTER 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 FILTER WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED D131 KIDS INFANT ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND-ALONE FILTER (CATALOGUE NUMBER 050542) IS REGISTERED IN THE USA (510(K) NUMBER: K072308). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE FILTER WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE FILTER. THE INCIDENT OCCURRED IN FINLAND. REPORTEDLY, THE EVENT OCCURRED IN THE MIDDLE OF THE PROCEDURE AND NO PROBLEM WAS OBSERVED IN THE CIRCUIT BEFORE STARTING THE CASE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP ITALIA RECEIVED REPORT THAT, DURING PROCEDURE, THE ARTERIAL FILTER WAS FOUND TO BE CRACKED AND BLOOD LEAKAGE OCCURRED. REPORTEDLY, THE FILTER WAS BYPASSED AND THE OPERATION CONTINUED WITHOUT ANY OTHER PROBLEM. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34760 D131 KIDS INFANT ARTERIAL FILTER FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA SRL DIDECO KIDS 2509110047

    Patients

    Seq Age Sex Outcome Treatment
    1