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

Device Problems Break (1069); Difficult to Open or Close (2921); Fail-Safe Problem (2936)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

Supply cabinet doors on medselect flex automated medication dispensing machines periodically do not open.We have two cabinets that currently have supply cabinet doors that when locked, do not open when a medication in this location and should open for removal.Original tickets submitted 5/19/23 and 5/21/23.Today our third party vendor came to fix the cabinet doors.The outcome was the door ended up getting completely stuck and even the key would not open the door.Technical support at arxium was called and we were unable to get the support needed to get the door re-opened.Due to the location of the medselect flex - this was in our medication room in our icu and that no medications were controlled, our facilities department pried open and broke the lock so that medications can be removed from the cabinet in the event of an emergency - arxium agreed this was the only option to get the door open.We are awaiting parts for a new door and lock.Our ed location cabinet still does not open if the door gets shut.It must be opened with a key.This is a major issue as these supply cabinets are part of medselect flex cabinets in our ed and icus because they contain pre-made vasoactive drips and other emergency medications and we must have the doors open when a medication is selected.Reference report #mw5117882.

• Brand Name: MEDSELECT FLEX AUTOMATED DISPENSING MEDICATION CABINET - SUPPLY CABINET MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): ARXIUM, INC.; buffalo grove IL
• MDR Report Key: 17009758
• MDR Text Key: 316150610
• Report Number: MW5117883
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1