BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MC3 CRESCENT RA DUAL LUMEN CATHETER 19FR

    MDR report key: 14840611 · Received June 28, 2022

    Report

    Report Number
    14840611
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 16, 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 ON VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO) SUPPORT. THE PATIENT WAS CANNULATED WITH A MC3 19FR MEDTRONIC CANNULA. IMAGING REVEALED A PERICARDIAL EFFUSION, A DRAIN WAS PLACED WHICH DRAINED APPROXIMATELY 160CC OF FLUID. THE PERICARDIAL DRAIN REMAINED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910810 MC3 CRESCENT RA DUAL LUMEN CATHETER 19FR DUAL LUMEN ECMO CANNULA PZS MICHIGAN CRITICAL CARE CONSULTANTS, INC. 70419

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA Female