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

Device Problems No Display/Image (1183); Difficult to Open or Close (2921); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  Injury  

Event Description

Patient scheduled for redo mvr/avr.While on cardiopulmonary bypass, crna attempting to draw up medications patient needed to come off bypass.Omnicell completely shut down.Touch screen went blank, unable to open monitor, or any drawers including equipment drawers.Was "dead" for at least 5 min.Eventually a reboot type screen came back up.In the meantime, i had to use emergency bypass button to access drawers.

• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 12273695
• MDR Text Key: 264988730
• Report Number: 12273695
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening