MAUDE Adverse Event Report: DATA INNOVATIONS LLC DATA INNOVATIONS INSTRUMENT MANAGER V.8.XX; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number V8 XX

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

We are using medical blood device bk180245.Instrument manager v8.This morning around 3am mst the information technology department rebooted both the primary and high availability servers at the same exact time without performing the proper sequence for reboot of this fda cleared blood establishment software.They did not shut down the instrument manager software, nor the cache databases on either server, nor failover the database from the primary to the high availability server and perform the software updates one server at a time to ensure the integrity of the fda approved blood establishment software to maintain its validation.At this time (laboratory services), we are not experiencing any data corruption as far as we can tell but we are not experts in data corruption analysis.

• Brand Name: DATA INNOVATIONS INSTRUMENT MANAGER V.8.XX
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS LLC
• MDR Report Key: 16113031
• MDR Text Key: 306890877
• Report Number: MW5114195
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V8 XX
• Device Catalogue Number: BK180245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other