MAUDE Adverse Event Report: ARXIUM INC. MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problems Product Quality Problem (1506); Application Program Problem (2880); Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

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, mw5117679, mw5117680, mw5117681, mw5117682, mw5117683, mw5117684, mw5117685, mw5117686, mw5117687, mw5117688, mw5117689, mw5117690, mw5117691, mw5117692, mw5117693, mw5117694, mw5117695, mw5117696, mw5117697, mw5117698, mw5117699, mw5117700, mw5117701, mw5117702, mw5117704, mw5117705, mw5117706, mw5117707.

• Brand Name: MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): ARXIUM INC.; buffalo grove IL
• MDR Report Key: 16962179
• MDR Text Key: 315699879
• Report Number: MW5117703
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1