BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEK DUO

    MDR report key: 20155537 · Received September 6, 2024

    Report

    Report Number
    20155537
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 9, 2024
    Report Date
    August 9, 2024
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A 29 FR VENO-VENOUS DUAL LUMEN CANNULA WAS OPENED TO THE STERILE FIELD BY THE CIRCULATING NURSE. PRIOR TO THE INSERTION OF THE CANNULA INTO THE PATIENT, DR. NOTICED A CRACK IN THE DISTAL END OF THE CANNULA. THE CANNULA WAS NOT INSERTED INTO THE PATIENT. A NEW AND UNDAMAGED 29 FR VENO-VENOUS DUAL LUMEN CANNULA WAS OPENED TO THE STERILE FIELD BY THE CIRCULATING NURSE AND INSERTED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886713 PROTEK DUO CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIAC ASSIST, INC. 5140-4629 389065

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female