MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS SAFETRACE TX® 3.12.0P1; SAFETRACE TX 3.12.0P1

Model Number STTXV3.12.0P1

Device Problem Computer Software Problem (1112)

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

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Haemonetics has identified the issue: if the safetrace tx database is down or is unreachable, such as after a network change or interruption, and the downtime snapshot process is run while the database cannot be reached by that process, the process aborts and the patient_downtime.Sqlite file that is created cannot be accessed by the users.In addition, the users are unable to create a new manual patient_downtime.Sqlite file if the connectivity to the safetrace tx database has been lost.The current users of this software will be notified through a product technical bulletin of the following: rename or move a previous patient_downtime.Sqlite file to a new location on the server running the downtime process and on the downtime workstations in the blood bank, so that the users can still access the last good file of historical patient data when the downtime snapshot creation process is unable to reach the database and/or creates a corrupted patient_downtime.Sqlite file.The issue will be addressed in the release of safetrace tx v3.13.0.

Event Description

On (b)(6) 2017 a customer reported that their downtime snapshot file was not available to users at all of their facilities during a recent database downtime.The downtime was caused by an it/dba altering disk paths on their unix server which houses the safetrace tx databse, during which time the users were also unable to access safetrace tx program manager.The downtime database provides access to view critical patient information that will allow the transfusion service to continue to issue blood when the computer information system is not available.The downtime database consists of a snapshot of the production database at a given point in time.The downtime snapshot can either be created on one machine and then copied to the client machines, or it can be set up to run on each client machine individually.The initial snapshot of the production database is typically taken when system use is at a minimum.The timing and the frequency of the snapshots are determined by the user.Once a downtime database snapshot exists in a specific location, running the downtime process to that location will cause the downtime snapshot to be updated and not recreated.To create another full snapshot in a location where the same snapshot already exists, the customer must either rename the current snapshot or move it to a different location.During a recent database downtime, the scheduled task that creates the new patient_downtime.Sqlite file had automatically started, deleted the previous patient_downtime.Sqlite file (as defined by the scheduled task setup), then attempted to run the proc_download.Exe program to create a new downtime file; but the process aborted as it was not able to reach the database to successfully create the new file.This generated an unusable (i.E.Invalid) copy of the patient_downtime.Sqlite.The scheduled task then copied this unusable file to the downtime workstations in the blood bank locations.When the users attempted to access the downtime file on the workstation the message: gt885 message text: "invalid downtime file - %1" displayed and the users were not able to access any historical patient information.Because the database was down / not accessible, the users were also unable to create a new manual downtime snapshot file at that time.During this time, the user was not able to access a patient's information for an urgent transfusion since the file was unusable and their database was down.This resulted in a patient receiving non-irradiated blood product when they required irradiated blood product.It is unknown if there was an adverse event to the patient.

• Brand Name: SAFETRACE TX® 3.12.0P1
• Type of Device: SAFETRACE TX 3.12.0P1
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6700227
• MDR Text Key: 80058751
• Report Number: 2951268-2017-00001
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: STTXV3.12.0P1
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1