BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8415473 · Received March 13, 2019

    Report

    Report Number
    1646848-2018-00004
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    July 13, 2016
    Report Date
    January 7, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING SUBMITTED IN RESPONSE TO FDA REPORT (B)(4). THE LOT NUMBER IS UNKNOWN. THIS REPORT IS BEING PREPARED AND SUBMITTED BY THE MANUFACUTRER IN RESPONSE TO THE MEDWATCH REPORT NOTED ABOVE.

    Description of Event or Problem · 1

    AN ORIGEN 13 FRENCH ECMO CATHETER WAS REPORTED TO BE INTRODUCING AIR IN THE ECMO CIRCUIT X 2 DURING PATIENT ADMIT. IT IS UNCLEAR HOW THE AIR WAS ENTERING. THERE IS SOME CONCERN THAT IT IS FROM THE CANNULA EVEN THOUGH THERE IS NO OBVIOUS DEFECT. DEVICE FAILED (BROKE) COULDN'T GET IT TO WORK OR IT STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209611 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC. VV13F

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other