BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNICELL I.V.SOFT ROBOT STATION

    MDR report key: 11874875 · Received May 24, 2021

    Report

    Report Number
    MW5101521
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 16, 2021
    Report Date
    May 21, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED ISSUES WITH CORING WHILE USING OMNICELL I.V.SOFT ROBOTS TO COMPOUND. SMALL CORES OF RUBBER FROM VIAL STOPPER FOUND ON (B)(6) 2020 IN ROCURONIUM. CONTACTED MANUFACTURER WHO ADVISED A CHANGE FROM HOSPITAL ROCURONIUM TO XGEN ROCURONIUM. CHANGE MADE AS SUGGESTED WITH CONTINUED FINDING OF RUBBER CORES WITH THE XGEN ROCURONIUM. IN ADDITION CORES DISCOVERED WITH VASOPRESSIN. DECISION MADE TO PAUSE USE OF DEVICE BASED ON FREQUENCY OF CORING OBSERVED. VENDOR (OMNICELL) TESTED USE OF FILTER NEEDLE AND RESUMED PRODUCTION IN (B)(6) OF 2021 WITH USE OF FILTER NEEDLE TO FILTER OUT ANY CORES. AT PRESENT ONLY ABLE TO SAFELY COMPOUND SYRINGES (STRAIGHT DRAW FROM VIAL) WITH FILTER NEEDLE. NOT ABLE TO USE FUNCTIONALITY OF COMPOUNDING BAGS DUE TO ISSUES WITH CORING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765377 OMNICELL I.V.SOFT ROBOT STATION SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP OMNICELL, INC.
    765378 OMNICELL I.V.SOFT ROBOT STATION SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP OMNICELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R