BEUDAMED
    FDA Adverse Event Death Summary report: N

    MC3 CRESCENT DUAL LUMEN CATHETER

    MDR report key: 13441948 · Received January 24, 2022

    Report

    Report Number
    13441948
    Event Type
    Death
    Date Received
    January 24, 2022
    Date of Event
    January 12, 2022
    Report Date
    January 24, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LUNG TRANSPLANT PT ON ECMO 42 DAYS, R IJ SITE SECURED W/ DACRON GRAFT, AIR ENTRAINMENT ALARMED, TEAM UNABLE TO DETERMINE SOURCE, GRAFT REMOVED FOR INSPECTION, REVEALED FRACTURE OF CANNULA, AIR ENTERED CIRCUIT, PATIENT UNABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450907 MC3 CRESCENT DUAL LUMEN CATHETER ECMO CATHETER PZS MC3 INC. 70132 2110149 OR 2111142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Death ECMO CIRCUIT -12/02/2021-01/12/2022