MAUDE Adverse Event Report: OMNICELL; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number G4

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 06/25/2019

Event Type  Injury  

Event Description

Keppra 1500mg was ordered, nurse pulled ketamine 1500mg out of omnicell, by typing in 'ke', pulled out the drug and did not realize it was ketamine, and administered.Omnicell, (b)(6).Fda safety report id# (b)(4).

• Brand Name: OMNICELL
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• MDR Report Key: 9203057
• MDR Text Key: 162981616
• Report Number: MW5090453
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 99