BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN DUAL LUMEN CATHETER

    MDR report key: 8472109 · Received April 2, 2019

    Report

    Report Number
    1646848-2019-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 18, 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
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 15F CATHETER WAS RECEIVED BACK AND IT APPEARS TO HAVE BEEN SUCKED FLAT BY SUCTION PRESSURE ON THE DRAINAGE SIDE. IT WAS ALSO BADLY KINKED, AND THE REINFUSION LUMEN WAS PARTIALLY OBSTRUCTED AS WELL. THE WHITE POLYURETHANE CATHETERS ARE NOT REINFORCED AND FOR USE WITH ROLLER PUMPS ONLY. THE INSTRUCTIONS FOR USE SUPPLIED WITH THAT CATHETER STATE, "SUCTION: WARNING: THE UNREINFORCED CATHETER MAY COLLAPSE IF SUCTION PRESSURE LESS THAN -50 MM HG IS APPLIED TO THE DRAINAGE LUMEN".

    Description of Event or Problem · 1

    PATIENT PLACED ON ECMO ON (B)(6) 2016. CANNULATION WENT SMOOTHLY. SURGEONS DID NOT FEEL THE 18F WOULD FIT SO A 15F WAS PLACED. INITIAL FLOWS WERE 1.14 WITH RPMS OF 3465. NEGATIVE PRESSURES -100 (THE BOX USED ONLY MEASURES TO -100). VOLUME GIVEN TO PATIENT AND ANTIHYPERTENSIVES STARTED. WAITED FOR PATIENT TO SETTLE AND HOPED THAT FLOWS AND RPMS WOULD CORRECT. BLOOD PRESSURE CAME DOWN AND THERE WAS NEVER REALLY ANY IMPROVEMENT IN RPMS OR FLOWS. THE KINK WAS NOT DISCOVERED UNTIL THE CANNULA WAS REMOVED. CANNULA WAS CHANGED ON (B)(6) 2016 TO THE 18F, REINFORCED CANNULA. THE SAME ISSUE OCCURRED AND IT HAS COLLAPSED AS WELL. IT FLATTENED OUTSIDE THE INCISION AND WILL NEED TO CHANGE IT. AT THIS POINT AFTER 2 CANNULAS WITH THE SAME ISSUES, USER BELIEVES IT IS SOMETHING ABOUT THE PATIENT. CIRCUIT IS VERY CLEAN, NO ISSUES WITH ANTICOAGULATION AND THE 18F SHOULD BE THE CORRECT SIZE FOR THE PATIENT AND FLOWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269550 ORIGEN DUAL LUMEN CATHETER VV ECMO CATHETER DWF ORIGEN BIOMEDICAL, INC VV15F M17983

    Patients

    Seq Age Sex Outcome Treatment
    1