BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM DUAL LUMEN CANNULA 31F

    MDR report key: 14653110 · Received June 10, 2022

    Report

    Report Number
    3016746283-2022-00004
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 2022
    Manufacturer
    QURA S.R.L.
    Product Code
    DWF
    UDI-DI
    08051160300792
    PMA / PMN Number
    K203067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    QUANTUM DUAL LUMEN VENOUS. "I JUST WANTED TO BRING TO YOUR ATTENTION AN ISSUE WE HAD TODAY WITH A SPECTRUM CANNULA. ONE OF OUR CURRENT PATIENTS, BEGAN ENTRAINING AIR FROM THE VENOUS SIDE IF THE NECK OR CANNULA WERE MANIPULATED IN ANY WAY. WE EXCHANGED THE CANNULA IN THE OPERATING ROOM AND THE ATTACHED VIDEO IS OF THE SPECTRUM CANNULA ONCE IT WAS REMOVED FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630457 QUANTUM DUAL LUMEN CANNULA 31F DUEL LUMEN CANNULA DWF QURA S.R.L. DL31F-VO D002352 08051160300792

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention