BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER INJECTABLE INFUSION SET

    MDR report key: 8491171 · Received April 8, 2019

    Report

    Report Number
    8491171
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 27, 2019
    Report Date
    March 6, 2019
    Manufacturer
    POWERLOC MAX
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ASSESSMENT OF PATIENT BLOOD NOTED ON PAD UNDER PATIENT. LA LINE NOTED TO BE "CRACKED/BROKEN/DISCONNECTED". THE TIP OF THE CATHETER WAS NOTED TO BE BROKEN OFF IN THE TRIFUSE. (SEE ACTUAL TRIFUSE THAT WAS SAVED). A MD WAS CALLED TO THE BEDSIDE IMMEDIATELY AND A STERILE GAUZE, KELLY CLAMP AND TEGADERM WAS PLACED. CARDIAC SURGERY WAS CALLED IMMEDIATELY BY THE MD WHILE HE WAS AT THE BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285825 POWER INJECTABLE INFUSION SET FPA POWERLOC MAX

    Patients

    Seq Age Sex Outcome Treatment
    1