BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETRACE TX® 3.12.0P1

    MDR report key: 6700227 · Received July 11, 2017

    Report

    Report Number
    2951268-2017-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 12, 2017
    Report Date
    June 12, 2017
    Manufacturer
    HAEMONETICS CORPORATION SOFTWARE SOLUTIONS
    Product Code
    MMH
    PMA / PMN Number
    BK150360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484688 SAFETRACE TX® 3.12.0P1 SAFETRACE TX 3.12.0P1 MMH HAEMONETICS CORPORATION SOFTWARE SOLUTIONS STTXV3.12.0P1

    Patients

    Seq Age Sex Outcome Treatment
    1