BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 CRESCENT RA DUAL LUMEN CATHETER 13FR

    MDR report key: 14840613 · Received June 28, 2022

    Report

    Report Number
    14840613
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 20, 2022
    Manufacturer
    MICHIGAN CRITICAL CARE CONSULTANTS, INC.
    Product Code
    PZS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BEING SUPPORTED WITH VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO) AND WAS CANNULATED WITH A MEDTRONIC 13FR MC3 CANNULA. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIAL DRAIN. THE MEDTRONIC MC3 CANNULA CONTRIBUTED TO THE DEVELOPMENT OF THE PERICARDIAL EFFUSION.

    Description of Event or Problem · 0

    PATIENT WAS BEING SUPPORTED WITH VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO) AND WAS CANNULATED WITH A MEDTRONIC 13FR MC3 CANNULA. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIAL DRAIN. THE MEDTRONIC MC3 CANNULA CONTRIBUTED TO THE DEVELOPMENT OF THE PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910812 MC3 CRESCENT RA DUAL LUMEN CATHETER 13FR DUAL LUMEN ECMO CANNULA PZS MICHIGAN CRITICAL CARE CONSULTANTS, INC. 70413

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female