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

Device Problem Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Date 05/11/2023

Event Type  malfunction  

Event Description

Medselect flex automated med dispensing cabinet's connection between hardware and software frequently malfunctions requiring hospital pharmacy staff to go to location and complete a hard reboot of the machine.Common errors include computer screen freezing, software "dispensing" and removing from counts, but drawers to do not open.This is leading to delays in accessing patient medications in our eds and patient units as well as procedures delay in our endoscopy suites.Date of event above is only one of many examples with this company.

• Brand Name: MEDSELECT FLEX AUTOMATED MEDICATION DISPENSING CABINETS
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): ARXIUM INC.
• MDR Report Key: 16953770
• MDR Text Key: 315549777
• Report Number: MW5117646
• 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: 05/15/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other