BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    MDR report key: 10821608 · Received November 11, 2020

    Report

    Report Number
    1718850-2020-00041
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 12, 2020
    Report Date
    October 12, 2020
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622140020
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LIVANOVA USA INC. MANUFACTURES THE CONVENIENCE PACK. THE INCIDENT OCCURRED IN (B)(6), UNITED STATES. THE COMPLAINED CIRCUIT WAS RETURNED TO LIVANOVA 30 OCT 2020. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS, NON-CONFORMITIES OR MATERIAL SCRAP/REQUESTS RELEVANT TO THE REPORTED ISSUE. BASED ON LIVANOVA INVESTIGATION, A POTENTIAL ROOT CAUSE OF THE TUBING DISCONNECTION COULD BE AN ALTERATION OF THE CHEMICAL/MECHANICAL CHARACTERISTICS OF THE TUBINGS. THE RISK ASSOCIATED TO THE EVENT IS ACCEPTABLE. NO SPECIFIC ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 1

    LIVANOVA USA INC. HAS RECEIVED A REPORT THAT, DURING BYPASS PROCEDURE, THE TUBING FROM THE OUTLET OF THE CENTRIFUGAL PUMP INTO THE OXYGENATOR INLET, FELL OFF. THE MEDICAL TEAM ELECTED TO ADMINISTER BLOOD BANK TO THE PATIENT. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290335 TUBING, PUMP, CARDIOPULMONARY BYPASS SMARXT TUBING AND CONNECTORS DWE LIVANOVA USA INC 2004400020 00803622140020

    Patients

    Seq Age Sex Outcome Treatment
    1