BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS

    MDR report key: 16961694 · Received May 18, 2023

    Report

    Report Number
    MW5117679
    Event Type
    Malfunction
    Date Received
    May 18, 2023
    Date of Event
    March 24, 2022
    Report Date
    May 16, 2023
    Manufacturer
    ARXIUM, INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FIRST TICKET FOR THIS PROBLEM WAS SUBMITTED (B)(6) 2022. OUR NEW ARXIUM MEDSELECT-FLEX MEDICATION DISPENSING CABINETS ARE LOSING INTERFACE/ORDER CONNECTIVITY ACROSS ALL 32 CABINETS AT 4 SITES - HOSPITAL, 2 CRITICAL ACCESS HOSPITALS, AND ONE ED(EMERGENCY DEPT)/URGENT CARE SITE. THIS HAS BEEN ONGOING OFF AND ON SINCE THAT TIME. THE VENDOR DOES NOT MONITOR THEIR SERVERS 24/7 SO ARE NOT AWARE THAT THEY ARE DOWN, MAKING NON-OVERRIDABLE MEDICATION ORDERS UNAVAILABLE TO BE ACCESSED FROM THE MEDICATION CABINETS. THIS IS CAUSING THE PHARMACY TEAM, WHEN IT IS REPORTED, TO PLACE ALL MACHINES INTO A GLOBAL OVERRIDE MODE UNTIL OUR IT(INFORMATION TECHNOLOGY) OR PHARMACY DEPARTMENT PLACES A TICKET WITH THE VENDOR THAT THE VENDOR'S SERVER IS DOWN AND NEED TO BE ADDRESSED. IT APPEARS THE SOFTWARE SYSTEM IN USE PERIODICALLY SENDS AN ERRONEOUS EXTRA MESSAGE ACROSS THE VENDOR INTERFACE WHICH CAUSES THE VENDOR'S SERVER TO SHUT DOWN. OUR HOSPITAL INTERFACE TEAM HAS SET UP A SCRIPT TO RUN ON TIMED INTERVALS TO HELP US SEE IF THE VENDOR'S SERVER IS NOT WORKING AND REQUIRES US TO SUBMIT A TICKET AS ABOVE. THIS CAUSES DISRUPTION IN PATIENT CARE IF NURSING STAFF CANNOT PULL THE MEDICATION BECAUSE NO ORDER CROSSED TO THE ADS MEDICATION CABINET. IT ALSO DECREASES OVERALL PATIENT SAFETY BY USING GLOBAL OVERRIDES TO PULL MEDICATIONS FROM THE MACHINE NOT BASED ON A SPECIFIC ORDER. OTHER DELAYS IN PATIENT CARE DUE TO PHARMACY STAFF RUNNING UP MEDICATIONS NOT BEING ACCESSED OFF ORDERS OR TROUBLESHOOTING THE PROBLEMS/CALLING IN TICKETS TO THE VENDOR SUPPORT DESK THAT CANNOT ADDRESS THE ISSUE DIRECTLY. OVER THE YEAR, OUR HOSPITAL SITE HAS ASKED FOR UPDATES TO THIS ISSUE ON MULTIPLE OCCASIONS AND THE RECENT UPDATE IS THE VENDOR IS "WORKING ON IT". MEDSELECT FLEX SYSTEM CABINETS, SOFTWARE VERSION 9.0.1. WAS THIS DEVICE SERVICED BY A THIRD PARTY SERVICER? YES. REFERENCE REPORTS: MW5117676, MW5117677, MW5117678, MW5117680, MW5117681, MW5117682, MW5117683, MW5117684, MW5117685, MW5117686, MW5117687, MW5117688, MW5117689, MW5117690, MW5117691, MW5117692, MW5117693, MW5117694, MW5117695, MW5117696, MW5117697, MW5117698, MW5117699, MW5117700, MW5117701, MW5117702, MW5117703, MW5117704, MW5117705, MW5117706, MW5117707.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651325 MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP ARXIUM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown