BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING, PUMP, CARDIOPULMONARY BYPASS

    MDR report key: 12128532 · Received July 7, 2021

    Report

    Report Number
    1718850-2021-00036
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 9, 2021
    Report Date
    October 12, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DWE
    UDI-DI
    00803622138331
    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 · 0

    LIVANOVA RECEIVED A REPORT STATING THAT THE TUBING HAD DISCONNECTED FROM THE INLET CONNECTOR OF ANOTHER MANUFACTURER OXYGENATOR. THE ISSUE OCCURRED ABOUT THREE MINUTES AFTER THE INITIATION OF SUPPORT. NO PATIENT AFFECTED. IT WAS REPORTED THAT THE CIRCUIT WAS DRY ASSEMBLED AND CONNECTIONS WERE DOUBLE TIE BANDED USING A TIE GUN. THEREFORE, THE CONNECTION BETWEEN LIVANOVA TUBING AND THE OXYGENATOR WAS MADE BY THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS, NON-CONFORMITY OR MATERIAL SCRAP/REQUESTS RELEVANT TO THE REPORTED ISSUE. THE OXYGENATOR AND THE DISCONNECTED TUBING WERE RETURNED TO LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION COULD NOT IDENTIFY ANY CONNECTION ISSUES BETWEEN THE TUBING AND THE OXYGENATOR. MOREOVER, WALL THICKNESS AND ID OF THE TUBING WAS FOUND TO BE WITHIN SPECIFICATION. SIMILAR COMPLAINTS HAVE BEEN REGISTERED IN THE LAST 12 MONTHS ON DIFFERENT CUSTOMERS/PTS CODES. BASED ON ALL THE GATHERED INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED TUBING DISCONNECTION CAN BE TRACED BACK TO AN ALTERATION OF THE CHEMICAL / MECHANICAL CHARACTERISTICS OF THE TUBINGS (WHICH ARE SUPPLIED BY A LIVANOVA). HOWEVER, THIS COULD BE ENHANCED BY THE TUBING NOT BEING PROPERLY SECURED TO THE OXYGENATOR INLET. SUPPLIER OF THE TUBING HAS BEEN FORMALLY NOTIFIED OF THE ISSUE. AT THE MOMENT, NO OTHER CORRECTIVE ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Additional Manufacturer Narrative · 0

    UPDATED INITIAL REPORTER.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION HAS BEEN PROVIDED. LIVANOVA USA INC MANUFACTURES THE COMPLAINED CIRCUIT. THE INCIDENT OCCURRED IN USA. THE DEVICE WAS RECEIVED AT LIVANOVA USA INC FOR INVESTIGATION. PRELIMINARY INVESTIGATION CONFIRMED THE TUBING THICKNESS WAS IN SPECIFICATION. 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, ABOUT THREE MINUTES AFTER THE INITIATION OF SUPPORT, THE TUBING DISCONNECTED FROM THE INLET OF THE OXYGENATOR. THE OXYGENATOR WAS A MAQUET QUADROX. THE CIRCUIT WAS ASSEMBLED DRY AND CONNECTIONS WERE DOUBLE TIE BANDED USING A TIE GUN. MODEL AND CALIBRATION STATUS OF THE TIE GUN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028474 TUBING, PUMP, CARDIOPULMONARY BYPASS SMARXT TUBING AND CONNECTORS DWE LIVANOVA USA INC 1931100040 00803622138331

    Patients

    Seq Age Sex Outcome Treatment
    1