BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 20300015 · Received September 25, 2024

    Report

    Report Number
    20300015
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    March 23, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CATH THERM DIL SO2 8FR PA(SWAN-GANZ) WAS PLACED IN CATH LAB AND 2 OF THE 3-WAY STOPOCKS HAVE FAILED. ONE WAS ON THE INFUSION PORT AND THE OTHER WAS ON THE PA LINE WHICH CAUSE BLOOD TO BACK UP. BOTH LEAKED FROM A CRACK/HOLE ON THE SIDE OF THE "T".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244736 ICU MEDICAL CATHETER, OXIMETER, FIBER-OPTIC DQE ICU MEDICAL, INC. 50328 398374

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown