BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN REINFORCED DUAL LUMEN CATHETER

    MDR report key: 8472103 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00005
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Report Date
    January 10, 2019
    Manufacturer
    ORIGEN BIOMEDICAL, INC
    Product Code
    DWF
    PMA / PMN Number
    K113869
    Removal / Correction Number
    Z-1456-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THE CATHETERS, THEY WERE SANITIZED AND EXAMINED, AND WE CONFIRMED THE FAILURE MODE YOU REPORTED. AFTER RECEIVING THE REPORT OF THE DISCONNECTION, ALL CATHETERS AT THE MANUFACTURER PREMISES WERE 100% INSPECTED. IT WAS FOUND THAT ONLY CATHETERS IN LOT N18549 AND ANOTHER UNRELEASED LOT OF 13F CATHETERS SHOWED POTENTIAL FOR THE CLEAR EXTENSION TUBE TO DISCONNECT AFTER A PULL TEST. THE PROBLEM WAS NOT FOUND IN ANY OTHER SIZE OR LOT OF CATHETERS. IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN ADHESIVE FAILURE. IT APPEARS FROM TESTING THAT BOND STRENGTH IN THESE TWO LOTS DRAMATICALLY DECREASES OVER TIME, WITH UNITS IN ACCELERATED AGING FOR A YEAR HAVING VERY LITTLE RESISTANCE TO PULL STRENGTH. THIS MAY BE WHY THE UNITS INITIALLY PASSED QA PULL TESTING BUT PULLED APART IN THE FIELD. CORRECTIVE ACTIONS HAVE BEEN PUT IN PLACE.

    Description of Event or Problem · 1

    THE CLEAR TUBE BECAME DETACHED FROM THE MOLDED CATHETER HUB ON THE RETURN LUMEN ON A VV13F CATHETER FROM LOT N18549 AFTER THE PATIENT HAD ALREADY EXPIRED. THE PRODUCT WAS NOT BEING USED DURING THE ECMO PROCEDURE WHEN IT MALFUNCTIONED; THE DRAINAGE AND RETURN LUMENS HAD BEEN DISCONNECTED FROM THE ECMO CIRCUIT AND Y'D TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269549 ORIGEN REINFORCED DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV13F N18549

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R