BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART TUBING AND CONNECTORS

    MDR report key: 13791466 · Received March 17, 2022

    Report

    Report Number
    1718850-2022-00026
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Report Date
    July 12, 2022
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622136597
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INFORMATION HAS BEEN PROVIDED. EVENT DATE IS UNKNOWN LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN (B)(6), UNITED STATES OF AMERICA A. DEVICE HAS BEEN REQUESTED FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT STATING THAT, DURING A PROCEDURE, THE TUBING DISCONNECTED FROM THE OXYGENATOR INLET. THE UNIT WAS REQUESTED FOR FURTHER INVESTIGATION. WHEN THE DEVICE WAS RECEIVED AT LIVANOVA, IT WAS IDENTIFIED IT CONTAINED THE DEVICE OF ANOTHER COMPLAINT. LIVANOVA IS FOLLOWING UP WITH THE CUSTOMER TO CONFIRM THE COMPLAINED DEVICE IS NOT AVAILABLE. ACCORDING TO THE TECHNICAL DOCUMENTATION OF THE CIRCUIT, THE INVOLVED CONNECTION IS ASSEMBLED BY THE CUSTOMER. THEREFORE, 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. THE DHR REVIEW HIGHLIGHTED THAT THE LOT WHOSE CLAIMED PRODUCT BELONG TO WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. THE CIRCUIT ITEM CODE WAS NEVER COMPLAINED BY THE CUSTOMER, SO THE EVENT IS ISOLATED. 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. H3 OTHER TEXT : INCORRECT DEVICE RETURNED.

    Description of Event or Problem · 0

    THE PUMP CIRCUIT WAS SET-UP IN THE NORMAL CONFIGURATION AND THEY WERE ON BY-PASS. THE CENTRIFUGAL TUBING WAS ATTACHED AND TI-BANNED TO THE TERUMO OXYGENATOR, AND SUDDENLY THE TUBING BECAME DISCONNECTED TO THE INLET VALVE ON THE OXYGENATOR. THE PERFUSIONIST QUICKLY RE-ATTACHED THE TUBING, WITH A VERY SMALL AMOUNT OF BLOOD BEING LOST IN THE PROCESS OF RE-ATTACHING THE TUBING. THIS WAS THE FIRST TIME THIS HAD HAPPENED WITH THE TUBING AND THE OXYGENATOR.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291151 SMART TUBING AND CONNECTORS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC 2010000043 00803622136597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown