BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM DUAL LUMEN CANNULA 31F

    MDR report key: 15354950 · Received September 5, 2022

    Report

    Report Number
    3016746283-2022-00005
    Event Type
    Malfunction
    Date Received
    September 5, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 20, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MOVED WARNING TO FIRST PAGE OF THE IFU: DO NOT ALLOW ALCOHOL, ALCOHOL-BASED LIQUIDS, ETHERS, HALOGENATED LIQUIDS OR CORROSIVE SOLVENTS TO COME INTO CONTACT WITH THE DEVICE. THIS WOULD CAUSE DAMAGE SUCH AS TO COMPROMISE THE INTEGRITY AND FUNCTIONALITY OF THE DEVICE.

    Description of Event or Problem · 0

    PT SUPPORTED ON VV ECMO WITH A DLCA SINCE 1/31. THE TEAM REPORTED AN EVENT TODAY 5/19 WHERE THE CANNULA SEPARATED AT THE VENOUS Y. THEY ATTEMPTED TO TIE BAND THE CONNECTION BUT WERE UNABLE TO SECURE AND SO THE PATIENT WAS RECANNULATED TO VA ECMO. PATIENT WELFARE INFORMATION - OFF ECMO - RECEIVED A BILATERAL LUNG TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486052 QUANTUM DUAL LUMEN CANNULA 31F DUEL LUMEN CANNULA DWF QURA S.R.L. DL31F-VO D002352 08051160300792

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male Required Intervention