BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS HLS CANNULA 25F

    MDR report key: 11633491 · Received April 8, 2021

    Report

    Report Number
    11633491
    Event Type
    Death
    Date Received
    April 8, 2021
    Date of Event
    March 27, 2021
    Report Date
    April 1, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AIR IN CANNULA WAS NOTED. UPON FURTHER INVESTIGATION, CANNULA WAS FOUND TO BE CRACKED NEAR THE CONNECTOR CLOSEST TO THE INSERTION SITE AND BLOOD WAS LEAKING FROM THE CRACK. EVENTUALLY CANNULA BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532340 VENOUS HLS CANNULA 25F CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Death