BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING

    MDR report key: 14432708 · Received May 18, 2022

    Report

    Report Number
    9680841-2022-00025
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 19, 2022
    Report Date
    July 13, 2022
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT. THE D731 MICRO 27 ARTERIAL FILTER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE ARTERIAL FILTER WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED D731 MICRO 27 ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE D731 MICRO 27 ARTERIAL FILTER IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K112525). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE D731 MICRO 27 ARTERIAL FILTER WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE D731 MICRO 27 ARTERIAL FILTER. THE INCIDENT OCCURRED IN MORRISTOWN, UNITED STATES OF AMERICA. THE INVOLVED DEVICE HAS BEEN DISCARDED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE HAS BEEN DISPOSED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT DURING PRIMING A MOBILE WHITISH PLASTIC PARTICLE WAS FOUND INSIDE THE ARTERIAL FILTER. NO PICTURE OR VIDEO WAS AVAILABLE, AND THE UNIT WAS DISCARDED. DURING FOLLOW-UP ACTIVITY, IT COULD NOT BE ESTABLISHED IF THE PARTICLE WAS LOCATED BEFORE OR AFTER THE FILTER MESH. INVOLVED LOT OF ARTERIAL FILTER WAS ALREADY COMPLAINED BY THIS SAME CUSTOMER FOR SIMILAR ISSUE. IT CANNOT BE RULED OUT THAT WHITISH PARTICLE WAS A WELDING FLASH REASONABLY RESULTING FROM THE WELDING PHASE OF THE POLYCARBONATE, FROM WHICH THE FILTER IS MADE. THE RISK IS IN THE ACCEPTABLE REGION. NO CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING PRIMING OF A CIRCUIT, PARTICULATE MOVABLE MATTER WAS NOTICED INSIDE THE D731 MICRO 27 ARTERIAL FILTER. THE MEDICAL TEAM HAS CUT THE FILTER OUT AND REPLACED IT WITH ONE FROM THE INVENTORY. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891349 D731 MICRO 27 ARTERIAL FILTER WITH 27 MICRON PHISIO COATING FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE DTM SORIN GROUP ITALIA SRL 2105250145

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown