BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 11699940 · Received April 21, 2021

    Report

    Report Number
    11699940
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ROLLED OVER IN BED AND WHEN HE SAT UP, THE TUBING WITH BLINATUMOMAB FELL TO FLOOR, DISCONNECTED FROM CLEAR CAP ON SIP. THE REGISTERED NURSE CLAMPED SIP TUBING IMMEDIATELY AND NOTED THE SPLIT-SEPTUM ON THE CLEAR CAP OF THE MICROCLAVE¿ CONNECTOR WAS STUCK UP INSIDE CAP. MOST LIKELY IT WAS CAUSING A LOOSE/NOT SECURE CONNECTION TO THE SPIROS CLOSED MALE CONNECTOR ON THE END OF BLINATUMOMAB TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597111 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 2555 DA