BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V. STATION ONCO

    MDR report key: 11494130 · Received March 16, 2021

    Report

    Report Number
    3011278888-2021-00003
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 22, 2021
    Report Date
    May 26, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    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.

    Additional Manufacturer Narrative · 1

    REPAIR TECHNICIAN REVIEWED THE DEVICE AND CHECKED THE NEEDLE INSERTION AND DRUG PARAMETERS AND FOUND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THE ALLEGED FAILURE. THE DEVICE WAS FURTHER REVIEWED AND DETERMINED THAT THE NEEDLE AND PINCHER WERE RELATIVELY OLD, AND THEREFORE NEED TO BE REPLACED. THE PARTS WERE ORDERED FOR THE REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(4), THE ONCO STATION SPILLED 2 DOSAGES: THE FIRST WITH ENDOXAN + SPREADING (ABOUT 1.30 PM) AND THE SECOND WITH PACLITXEL + SPREADING (ABOUT 3.30 PM). NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390029 OMNICELL I.V. STATION ONCO PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION ONCO

    Patients

    Seq Age Sex Outcome Treatment
    1