BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TUBING AND CONNECTORS

    MDR report key: 12672320 · Received October 21, 2021

    Report

    Report Number
    1718850-2021-00047
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    December 1, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622147814
    PMA / PMN Number
    K981613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT THE QUICK CONNECTOR DISCONNECTED DURING A PROCEDURE. THE PATIENT WAS TRANSFUSED. THE COMPLAINED CONNECTION IS MANUALLY DONE BY THE CUSTOMER. THE ANALYSIS OF THE LIVANOVA COMPLAINT DATABASE REVEALED THAT NO OTHER SIMILAR COMPLAINT ON THIS CIRCUIT ITEM CODE. THUS, SUGGESTING THIS IS AN ISOLATED EVENT. THE DHR REVIEW DID NOT IDENTIFY ANY ISSUE. THE COMPLAINED QUICK CONNECTOR WAS INVESTIGATED AT LIVANOVA AND THE REPORTED CONDITION COULD NOT BE CONFIRMED ON THE RETURNED SAMPLE. THE SAMPLE WAS PRESSURIZED TO 15PSI FOR SIX HOURS, A FACTOR OF SAFETY OF 1.5 TO THE RATED 10PSI OF THE PTS PACK AND NO DISCONNECTION OR LEAKING WAS OBSERVED. THE CONNECTOR BEHAVED AS EXPECTED. BASED ON ALL THE ABOVE FACTS, IT CANNOT BE RULED OUT THAT AN IMPROPER CONNECTION DONE BY THE CUSTOMER COULD HAVE LED TO THE REPORTED DISCONNECTION. NO DEVICE MALFUNCTION COULD BE CONFIRMED. SINCE THE ROOT CAUSE WAS NOT IDENTIFIED, NO SPECIFIC ACTION WAS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN (B)(6) UNITED STATES OF AMERICA. THE DEVICE HAS BEEN RECEIVED AT LIVANOVA (B)(4). INITIAL INVESTIGATION RESULT COULD NOT REPRODUCE THE CLAIMED DISCONNECTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING A BYPASS, THE QUICK CONNECTORS BETWEEN THE OUTLET OF THE REVOLUTION PUMP AND THE INLET OF THE OXYGENATOR DISCONNECTED. THE QUICK CONNECTORS WERE PROVIDED ALREADY TIE BANDED. THE PATIENT WAS TRANSFUSED WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572083 SMART TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2122400056 00803622147814

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other