BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V.STATION ONCO

    MDR report key: 11267013 · Received February 2, 2021

    Report

    Report Number
    3011278888-2021-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 21, 2021
    Report Date
    May 26, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE MANUFACTURER OF THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. ADDITIONALLY, AS OF (B)(6) 2021, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THE CONTACT OFFICE OF THIS DEVICE WAS UPDATED FROM HEALTH ROBOTICS TO OMNICELL S.R.L, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO SECTIONS D3 AND G1.

    Description of Event or Problem · 1

    ON (B)(6) 2021 IT WAS REPORTED THAT IN THE MORNING THE PHARMACY REPORTED A SPILLAGE ISSUE WITH THE DRUG BEHIND THE SCALE. THE CAUSE OF THE SPILL WAS DUE TO MISALIGNMENT BETWEEN THE INJECTION NEEDLE AND BAG PORT; THE DRUG DOSER DID NOT ROTATE BEFORE TO INJECT THE DRUG INTO THE BAG. THE SOFTWARE WAS UPDATED TO THE NEW VERSION, (B)(4), TO CORRECT THE ISSUE 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
    164488 OMNICELL I.V.STATION ONCO PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION ONCO

    Patients

    Seq Age Sex Outcome Treatment
    1