BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 12576351 · Received October 5, 2021

    Report

    Report Number
    12576351
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 21, 2021
    Product Code
    FPA
    UDI-DI
    00840619023386
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME FROM HOME AS A DIRECT ADMIT AFTER IV TUBING BROKE AT THE SPIRO CONNECTION. PATIENT IS ON A CONTINUOUS BLINATUMOMAB INFUSION AT HOME. INFUSION RESUMED AND NO HARM WAS NOTED TO THE PATIENT. THERE HAVE BEEN SEVERAL REPORTS OF THIS TYPE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475354 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA 20130-01 00840619023386

    Patients

    Seq Age Sex Outcome Treatment
    1 1825 DA