BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8472114 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00010
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    July 13, 2016
    Report Date
    April 1, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE CATHETER WAS IMMEDIATELY DISINFECTED AND PHOTOGRAPHED FOR INVESTIGATION. THE CATHETER WAS RECEIVED AS SHOWN, WITH THE TIP CUT OFF; THE REST OF THE CATHETER WAS NOT RETURNED. A SMALL CIRCUIT WAS CREATED BY INSERTING THE CATHETER TIP INTO A CONTAINER OF WATER AND CONNECTING TUBES TO THE BARBS. A VACUUM WAS PULLED ON THE DRAINAGE LINE TO PULL THE WATER THROUGH THE VENOUS LUMEN. THE AIR LEAK COULD NOT BE RECREATED WITH FLUID IN BOTH LINES OF THE CIRCUIT. IT SHOULD BE NOTED THAT THE CATHETER WAS RECEIVED AND APPEARED TO BE SMEARED WITH AN ADHESIVE OR SEALANT ON THE CLEAR TUBES. SINCE THE LOT NUMBER WAS NOT REPORTED A SPECIFIC BATCH RECORD COULD NOT BE INVESTIGATED. BASED ON SALES RECORDS, THE LAST THREE LOTS OF VV13F CATHETERS SHIPPED TO NATIONWIDE (B)(6) HOSPITAL WERE ALL REVIEWED, NO DEVIATIONS WERE RECORDED ON THOSE LOTS. ALL CATHETERS ARE INSPECTED AND UNDERGO A PRESSURE TEST PRIOR TO RELEASE, AND ALL RELEASED CATHETERS IN THESE LOTS PASSED THIS PRESSURE LEAK INSPECTION. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED TO ORIGEN ON THESE LOTS OR OTHERS. BASED ON THIS INVESTIGATION, THE CAUSE FOR AIR IN THE CIRCUIT COULD NOT BE DETERMINED. WE WILL CONTINUE TO PRESSURE TEST ALL OUR CATHETERS AND MONITOR OUR COMPLAINTS FOR ANY SIMILAR ISSUES.

    Description of Event or Problem · 1

    AIR WAS NOTED TO BE IN THE ECMO CIRCUIT X2 DURING PATIENT ADMIT. IT IS UNCLEAR HOW THE AIR WAS ENTERING, THERE IS CONCERN THAT IT IS FROM THE CANNULA EVEN THOUGH THERE IS NO OBVIOUS DEFECT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269579 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV13F

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO