BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V.STATION

    MDR report key: 9787295 · Received March 4, 2020

    Report

    Report Number
    3011278888-2020-00008
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    February 11, 2020
    Report Date
    May 19, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    UDI-DI
    08056477790007
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF JANUARY 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.

    Description of Event or Problem · 1

    ON (B)(6) 2020 AN I.V. STATION DEVICE PASSED AN UNDERDOSED SYRINGE PREPARATION. THE SYRINGE WAS MISHANDLED AFTER IT WAS WEIGHED AND MARKED ACCEPTABLE BY THE DEVICE DUE TO IMPROPER FUNCTIONALITY OF THE NEEDLE REMOVER AND ROBOT PINCERS. THE NEEDLE REMOVER SENSOR AND NEEDLE GRIPPER PINCERS WERE REPLACED AND CALIBRATED TO PREVENT RECURRENCE OF THIS ISSUE. THE UNDERFILLED PREPARATION WAS IDENTIFIED AND THERE ARE NO KNOWN ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247692 OMNICELL I.V.STATION PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION 08056477790007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other