BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM DUAL LUMEN CANNULA 27F

    MDR report key: 16213214 · Received January 20, 2023

    Report

    Report Number
    3016746283-2023-00001
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 19, 2023
    Manufacturer
    QURA S.R.L.
    Product Code
    DWF
    UDI-DI
    08051160300808
    PMA / PMN Number
    K221353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION THE HOSPITAL HAD PROVIDED (DEVICE PHOTOS, XRAY, OTHER DATA) FOR THE INVESTIGATION MADE IT POSSIBLE TO IDENTIFY A PROBABLE CAUSE OF THE ISSUE. THE MECHANICAL BREAKAGE APPEARS TO BE DUE TO A FLEXION AT THE AREA WHERE THE CANNULA STARTED LEAKING.

    Description of Event or Problem · 0

    27FR DUAL LUMEN CANNULA NOTED TO BE LEAKING BELOW BIFURCATION OF CANNULA. PATIENT HAD BEEN ON FOR ALMOST A MONTH. CANNULA WAS REPLACED WITH ANOTHER 27FR DUAL LUMEN CANNULA WITHOUT ISSUE. POSITIVE PRESSURE MEASURING 350 ON LEAKING CANNULA. NO SUTURE WAS AT THE AREA WHERE THE CANNULA STARTING LEAKING, PERFUSIONIST SAID IT LOOKED MORE LIKE A POINT OF FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364377 QUANTUM DUAL LUMEN CANNULA 27F DUEL LUMEN CANNULA DWF QURA S.R.L. DL27F-VO E002593 08051160300808

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention