BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TUBING AND CONNECTORS

    MDR report key: 14166759 · Received April 21, 2022

    Report

    Report Number
    1718850-2022-00033
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    March 3, 2022
    Report Date
    July 21, 2022
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622136573
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN PITTSBURGH, PENNSYLVANIA, UNITED STATES OF AMERICA. COMPLAINED CIRCUIT HAS BEEN DISCARDED BY THE CUSTOMER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE DISCARDED BY THE USER.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING OF OUTLLET TUBING DISCONNECTION DURING A PROCEDURE. NO PATIENT/USER AFFECTED. UNIT IS NOT AVAILABLE. ACCORDING TO THE TECHNICAL DOCUMENTATION OF THE CIRCUIT, THE INVOLVED CONNECTION IS ASSEMBLED BY THE CUSTOMER. THIS WAS CONFIRMED ALSO THROUGH THE EVENT DESCRIPTION DETAILS, LIVANOVA LEARNED THAT THE LINE INVOLVED WAS CONNECTED BY THE CUSTOMER TO THE OUTLET OF A QUADROX OXY AND TIE BANDED. INDEED, THE INVOLVED CONNECTION WAS NOT PERFORMED DURING THE LIVANOVA MANUFACTURING. THE DHR REVIEW HIGHLIGHTED THAT THE LOT WHOSE CLAIMED PRODUCT BELONG TO WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. THE SAME CUSTOMER REPORTED ANOTHER SIMILAR EVENT ON THE SAME LOT 14 DAYS LATER. THE REPORTED DISCONNECTION CAN BE DUE TO A DEVIATION IN THE CHEMICAL CHARACTERISTICS OF THE TUBING (SUPPLIED BY AN EXTERNAL SUPPLIER) OR TO AN IMPROPER CONNECTION MADE BY THE CUSTOMER. INVESTIGATION OF SIMILAR PREVIOUS EVENTS DID NOT IDENTIFY ANY TUBING SIGNIFICANT MEASURABLE DEVIATION NOR ANY OTHER SPECIFIC REOCCURRENCE THAT COULD SUGGEST A SPECIFIC ROOT CAUSE (NO SPECIFIC REOCCURRENCE IN THE DISCONNECTION POINTS, BLOOD PRESSURES, CONNECTION TYPES, CONNECTIONS MADE BY LIVANOVA OPERATORS OR BY CUSTOMERS). HOWEVER, IT COULD BE NOT RULED OUT THAT UNTESTABLE MANUFACTURING AND CHEMICAL DEVIATIONS MAY HAVE CONTRIBUTED TO DISCONNECTION. THE RISK IS IN THE ACCEPTABLE REGION. NO 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 A ECLS SUPPORT, TWO DIFFERENT EVENTS OF LINE DISCONNECTION OCCURRED ON THE SAME PATIENT WITH THE SAME TUBING SET. THE FIRST DISCONNECTION (PRESENT REPORT) OCCURRED SHORTLY AFTER INITIATION ON (B)(6) 2022 FROM THE OUTLET OF A COMPETITOR OXYGENATOR. THE TUBING SET HAD BEEN ASSEMBLED DRY AS A STANDBY SETUP. THE TUBING WAS PUSHED FULLY ONTO THE OXYGENATOR OUTLET CONNECTOR AND TIE BANDED. THE SPECIFIC TIE GUN USED WAS NOT RECORDED. LINE PRESSURE WAS APPX 300MM HG. THE LINE WAS NOT UNDER TENSION. SUPPORT WAS RESUMED IN 1-2 MINUTES AFTER DE-AIRING AND RECONNECTING THE CIRCUIT. THE SECOND DISCONNECTION OCCURRED ON (B)(6) 2022 AND IS BEING REPORTED AS A SEPARATED MEDWATCH. 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
    2004322 SMART TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2203200053 00803622136573

    Patients

    Seq Age Sex Outcome Treatment
    1 Male