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

Catalog Number V8.13.04

Device Problem Failure to Convert to Back-Up (1048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

Data innovations' customer creative testing solutions was attempting to change to their failover/shadow server because their production server was down.They received a message "activation key is missing", and could not get the new system running.In troubleshooting it was determined the customer only moved the network cable from the primary system to the new system.This is not the correct way to switch to the failover/shadow system.Customer did not follow proper failover instructions.In addition, the temporary 7 day bypass key they were trying to use had already been used, and instrument manager would not allow them to use it a second time.The customer originally indicated "patient care is being affected.Cannot sort blood product".Data innovations has been unsuccessful in clarifying how "cannot sort blood product" is causing patient harm.Data innovations is filing this mdr due to the fact we cannot determine if patient harm has occurred.

• Brand Name: INSTRUMENT MANAGER SOFTWARE
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• Manufacturer (Section G): DATA INNOVATIONS LLC; 120 kimball avenue; suite 100; south burlington VT 05403
• Manufacturer Contact: heather hogan ; 120 kimball avenue; suite 100; south burlington, VT 05403 ; 8022643410
• MDR Report Key: 8927154
• MDR Text Key: 216679917
• Report Number: 1225673-2019-00009
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2019

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
• Device Catalogue Number: V8.13.04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1