BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D131 KIDS INFANT ARTERIAL FILTER

    MDR report key: 20310810 · Received September 26, 2024

    Report

    Report Number
    9680841-2024-00027
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 20, 2024
    Report Date
    January 28, 2025
    Manufacturer
    SORIN GROUP ITALIA SRL.
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED D131 KIDS INFANT ARTERIAL FILTER (CATALOG NUMBER 050542J) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE ARTERIAL FILTER ITEM 050542J IS SIMILAR TO THE ARTERIAL FILTER 050542, WHICH IS DISTRIBUTED IN THE USA. G.5. THE PRODUCT ITEM 050542J IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO THE ARTERIAL FILTER CATALOGUE 050542, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K072308 ). H11: SORIN GROUP ITALY MANUFACTURES THE D131 KIDS INFANT ARTERIAL FILTER. THE INCIDENT OCCURRED IN IZUMO, JAPAN. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: PART WAS RETURNED TO LIVANOVA FACILITY FOR INVESTIGATION. VISUAL EXAMINATION OF THE UNIT HIGHLIGHTED THAT THE BLUE FOREIGN PARTICLE WAS A REMAINING MATERIAL OF THE BLUE GASKET OF THE FILTER, EMBEDDED TO THE WELDING AND HENCE NOT ALONG THE BLOOD PATHWAY. TO CONFIRM THIS, A FLOW TEST WITH WATER WAS PERFORMED. SPECIFICALLY, THE DEVICE WAS FILLED WITH WATER PUMPED BY A ROLLER PUMP AT THE MAXIMUM FLOW RATE PERMITTED AS PER PRODUCT SPECIFICATIONS (2,5 LPM) WITH THE OUTLET AND PURGE LINES UNCLAMPED AND ENDING INTO A BECKER TO COLLECT THE ELUATE, WHICH WAS CHECKED FOR THE POSSIBLE PRESENCE OF THE PARTICULATE MATTER. THE PARTICLE REMAINED FIXED IN ITS POSITION AND DID NOT MOVE FOR THE ENTIRE DURATION OF THE TEST. THE LABORATORY TESTING RESULTS CONFIRMED THAT THE BLUE FIBROUS MATERIAL WAS INCORPORATED IN THE WELDING OF THE FILTER WITH NO CHANCE TO BE PHYSICALLY DISPLACED AND CHANNELED INTO THE PATIENT LINE. BASED ON THE INVESTIGATION RESULTS, THERE IS NO RISK THAT THE PARTICLE COULD BE CHANNELED INTO THE ARTERIAL LINE AND INFUSED TO THE PATIENT. THEREFORE, THE PRESENT CASE HAS BEEN RE-ASSESSED AS NOT REPORTABLE. BASED ON ALL THE ABOVE, THE COMPLAINED FILAMENTOUS MATERIAL WAS IDENTIFIED AS BEING A MANUFACTURING RESIDUE THAT SHOULD HAVE BEEN INTERCEPTED AT FINAL VISUAL CONTROLS IN LIVANOVA BEFORE PRODUCT RELEASE. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT WAS AN ISOLATED MANUFACTURING DEVIATION OCCURRED AT THE LIVANOVA FACILITY. TO PREVENT RE-OCCURRENCE, THE MANUFACTURING PERSONNEL HAS BEEN INVOLVED IN A DEDICATED TRAINING MEETING TO DISCUSS THE SPECIFIC EVENT.

    Description of Event or Problem · 0

    SORIN GROUP ITALY RECEIVED A REPORT OF A FOREIGN MATERIAL (0.3) DETECTED IN A KIDS ARTERIAL FILTER DURING INCOMING INSPECTION AFTER UNPACKING. IN DETAIL, THE PARTICLE APPEARS TO BE OUTSIDE OF THE FILTER NET MEMBRANE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238889 D131 KIDS INFANT ARTERIAL FILTER  FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA SRL. 050542J 2306020015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown