BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V.STATION ONCO

    MDR report key: 9758474 · Received February 26, 2020

    Report

    Report Number
    3011278888-2020-00006
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 5, 2020
    Report Date
    May 19, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO THE MANUFACTURER LISTED IN SECTIONS D3 AND G1.

    Description of Event or Problem · 1

    ON (B)(6) 2020 SPILLS INVOLVING CHEMOTHERAPY DRUG PREPARATIONS OCCURRED INSIDE THE I.V. STATION ONCO DEVICE. THE SPILLS WERE IDENTIFIED AND SUBSEQUENTLY CLEANED BY THE USER. A CAMERA DIDN'T APPROPRIATELY IDENTIFY THE SYRINGE NEEDLE WHICH CAUSED THE NEEDLE TO BE DAMAGED AND SUBSEQUENTLY MISS INJECTING DRUG INTO THE BAG PREPARATION. THE NEEDLE SEARCH CAMERA WAS REINITIATED TO RESTORE PROPER FUNCTIONALITY AND PREVENT RECURRENCE. THERE IS NO ADVERSE PATIENT EFFECT RELATED TO THIS DRUG SPILL WITHIN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216424 OMNICELL I.V.STATION ONCO PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION ONCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other