MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL AUTOMATED DISPENSING CABINET; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

There have been three occurrences reported by our nursing staff of our omnicell automated dispensing cabinets displaying discontinued medications on the nursing unit cabinet many months after the order was discontinued.Two occurrence were in (b)(6) 2021 and the third was this month, (b)(6) 2021.In the most recent case, the nurse reported the issue and omnicell needed to be contacted to resolve the issue as our ehr no longer displayed the discontinued medication to resend the discontinue message.In the most recent case, because the patient also had an active order on the profile the incorrect medication dose was given to the patient before the issue was identified.There was no patient safety impact identified.Mnicell identified the root cause after the two may occurrences as two asynchronous databases on their end.They ran an ocs list maintenance to sync the databases which removed the discontinued orders from the cabinet and let us know the issue would not recur.They were able to run the database sync again after the (b)(6) issue and that removed the order from the cabinet as it had in past occurrences of this issue.We have let them know about the third instance in (b)(6) and they are actively working our ticket to identify root cause and why it occurred again.Fda safety report id# (b)(4).

• Brand Name: OMNICELL AUTOMATED DISPENSING CABINET
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.
• MDR Report Key: 12894133
• MDR Text Key: 281547903
• Report Number: MW5105667
• 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: 11/24/2021

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: 11/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1