MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for SAFETRACE TX? 3.12.0P1 STTXV3.12.0P1 manufactured by Haemonetics Corporation Software Solutions.
[80058751]
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.
Patient Sequence No: 1, Text Type: N, H10
[80058752]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951268-2017-00001 |
| MDR Report Key | 6700227 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2017-06-12 |
| Device Manufacturer Date | 2016-03-11 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFETRACE TX? 3.12.0P1 |
| Generic Name | SAFETRACE TX 3.12.0P1 |
| Product Code | MMH |
| Date Received | 2017-07-11 |
| Model Number | STTXV3.12.0P1 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
| Manufacturer Address | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 EL DORADO HILLS CA 95762 US 95762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |