BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARXT TUBING AND CONNECTORS

    MDR report key: 11671616 · Received April 15, 2021

    Report

    Report Number
    1718850-2021-00028
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 16, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622112324
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED CIRCUIT WAS NOT MADE AVAILABLE FOR INVESTIGATION. LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN (B)(6) UNITED STATES. THE INVOLVED PARTS WERE NOT MADE AVAILABLE FOR RETURN. THE INVOLVED CONNECTION IS NOT PRE-ASSEMBLED AND IT WAS NOT TIED BANDED BY THE CUSTOMER AS SUGGESTED BY THE INSTRUCTION FOR USE. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. BASED ON THE INVESTIGATIONS PERFORMED FOR SIMILAR CASES, THE ROOT CAUSE OF THE REPORTED EVENT WAS TRACED BACK TO AN ALTERATION OF THE CHEMICAL / MECHANICAL CHARACTERISTICS OF THE TUBINGS (WHICH ARE PURCHASED BY A LIVANOVA SUPPLIER). THE SUPPLIER HAS BEEN FORMALLY INFORMED OF THE EVENT. THE RISK IS ACCEPTABLE. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 1

    LIVANOVA USA INC. HAS RECEIVED A REPORT THAT, DURING THE PROCEDURE THE INLET OF THE OXYGENATOR TUBING DISCONNECTED FROM THE CARDIOPULMONARY MACHINE. THE SYSTEM IS ALL PRECONNECTED EXCEPT THIS PRESSURE TUBING THAT DISLODGED DURING THE PROCEDURE. PATIENT OUTCOME WAS NOT PROVIDED. A 3500A REPORT (REF (B)(4)) WAS RECEIVED AT LIVANOVA ON 16 MAR 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572891 SMARXT TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2027400017 00803622112324

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR