BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPLEGIA ADAPTER CANNULA

    MDR report key: 8311195 · Received February 6, 2019

    Report

    Report Number
    1718850-2019-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    December 1, 2018
    Report Date
    May 24, 2019
    Manufacturer
    LIVANOVA USA, INC
    Product Code
    DWF
    UDI-DI
    00803622103681
    PMA / PMN Number
    K972503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE TWO RETURNED CA-20070 CANNULA DEVICES FOUND A VOID PATH IN THE CONNECTION BETWEEN THE CENTRAL CONNECTOR AND ONE OF THE TWO TUBING BRANCHES. THE RETURNED CANNULA DEVICES WERE SUBJECTED TO LEAK TEST AND THE TEST REPRODUCED THE CLAIMED LEAK. INVESTIGATION OF THE DEVICES SUGGESTED THE LEAK WAS CAUSED BY INCORRECT DISTRIBUTION OF BONDING SOLVENT BETWEEN THE TUBING AND CENTRAL CONNECTOR. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. THE OPERATORS INVOLVED IN THE MANUFACTURE OF THESE DEVICES WILL BE RETRAINED TO PREVENT FURTHER REOCCURRENCE. IN ADDITION, LIVANOVA HAS ISSUED A CAPA PROJECT (CAPA-ARV-2017-0006) TO FURTHER INVESTIGATE THE ROOT CAUSE FOR LEAKAGES ASSOCIATED TO THIS TYPE OF CANNULA DEVICES AND IDENTIFY ADEQUATE CORRECTIVE ACTIONS. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    LIVANOVA USA INC. MANUFACTURE THE CARDIOPLEGIA ADAPTER CANNULA. THE EVENT OCCURED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED ISSUE IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA INC. RECEIVED A REPORT THAT DURING CARDIOPLEGIA ADMINISTRATION A LEAK OF FLUID APPEARED AT THE Y CONNECTOR OF THE CARDIOPLEGIA ADAPTOR. IT WAS REPORTED RISK OF AIR DELIVERY TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105172 CARDIOPLEGIA ADAPTER CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF LIVANOVA USA, INC CA-XXXXX 1728200097 00803622103681

    Patients

    Seq Age Sex Outcome Treatment
    1