BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 14594883 · Received June 3, 2022

    Report

    Report Number
    1119779-2022-00808
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 7, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    UDI-DI
    00382904441500
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: THIS WAS LOGGED AGAINST SYNAPSYS MATERIAL #444150, SERIAL # (B)(6). THIS IS A CONFIRMED FAILURE OF A BD PRODUCT. LOCKED SAMPLES WERE UNLOCKED BY RESTARTING IIS. THE ISSUE IS CAPTURED IN SCR 278898 AND WILL BE FIXED IN A FUTURE RELEASE. DHR REVIEW IS NOT REQUIRED FOR STAND ALONE SOFTWARE. SOFTWARE OPERATION (OR FUNCTIONALITY) IS CONFIRMED AT TIME OF INSTALLATION. THE ROOT CAUSE WAS DUE TO A DATABASE ISSUE, THE QUEUE.QUEUEMESSAGES TABLE GREW IN SIZE. THE `TRYENQUEUESCHEDULEDMESSAGE` AND `DELETESCHEDULEDMESSAGE` THEN FAILED TO RE-SCHEDULE TIMED JOBS WHICH CAUSED THE SITE TO EXPERIENCE NEVER-UNLOCKING SPECIMENS. THE SCR IS TO REWRITE THE `DELETESCHEDULEDMESSAGETYPE` STORED PROCEDURE SO THAT IT WILL NOT SQL TIMEOUT. PER BALTRM-SYNAPSYS-APH REVISION 25, THE HAZARD ASSOCIATED WITH THIS COMPLAINT WOULD BE NO RESULT/DELAYED RESULT, WHICH IS AN S2; REFERENCE ID 6. COMPLAINTS FOR APPLICATION WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF MAY. NO TREND WAS DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD SYNAPSYS¿ THE SPECIMEN MANAGEMENT WORKFLOW WAS SIGNIFICANTLY DISRUPTED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYNAPSYS HAS A TIMED JOB WHICH CLEANS UP STALE SPECIMEN LOCKS. THE JOB IS SCHEDULED THROUGH A QUEUEING MECHANISM WE USE IN SYNAPSYS. THERE¿S A PERSISTENT DATABASE RECORD WHICH ¿RE-SCHEDULES¿ THE JOB TO ITS NEXT SCHEDULED TIME AFTER EACH RUN. THIS DATABASE RECORD WAS MISSING WHEN I LOGGED IN ON SATURDAY. TO RESTORE IT, ALL I DID WAS DO AN IISRESET ON THE SRV-SYN-01 SERVER (WHICH RESTARTS THE SYNAPSYS UI AND RESTORES THE MISSING RECORD)." "I¿VE OPENED AN SCR [278898] ON THE SYNAPSYS BACKLOG TO INVESTIGATE FURTHER AND WOULD LIKE TO GET PINGED ON ANY NEW ESCALATIONS." CUSTOMER PROBLEM: K - SYNAPSYS LOCKED INTO CULTURES - OVER 70 STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: ¿ DID NOTICE THAT THE BACKUP SERVER MEMORY WAS AT 72% USED DISPATCH PRIORITY DETERMINATION: Q1 ABLE TO PROCESS SAMPLES (Y/N)? Y, Q2 ABLE TO MAINTAIN WORKFLOW(Y/N)? N, PRIORITY: EMERGENCY IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE OVER 70 SAMPLES LOCKED IN SYNAPSYS. CUSTOMER CALLED TO SAY THAT THERE WERE OVER 70 SAMPLES LOCKED IN SYNAPSYS. THESE 70 WERE LOCKED FOR GREATER THAN THE 4 HOUR LOCK WINDOW. I LOGGED INTO THE BACKUP SERVER AND NOTICED THAT THERE WERE SOME FAILED WINDOWS UPDATES AS WELL AS OVER 70 PERCENT MEMORY WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD SYNAPSYS¿ THE SPECIMEN MANAGEMENT WORKFLOW WAS SIGNIFICANTLY DISRUPTED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYNAPSYS HAS A TIMED JOB WHICH CLEANS UP STALE SPECIMEN LOCKS. THE JOB IS SCHEDULED THROUGH A QUEUEING MECHANISM WE USE IN SYNAPSYS. THERE¿S A PERSISTENT DATABASE RECORD WHICH ¿RE-SCHEDULES¿ THE JOB TO ITS NEXT SCHEDULED TIME AFTER EACH RUN. THIS DATABASE RECORD WAS MISSING WHEN I LOGGED IN ON SATURDAY. TO RESTORE IT, ALL I DID WAS DO AN IISRESET ON THE SRV-SYN-01 SERVER (WHICH RESTARTS THE SYNAPSYS UI AND RESTORES THE MISSING RECORD)." "I¿VE OPENED AN SCR [278898] ON THE SYNAPSYS BACKLOG TO INVESTIGATE FURTHER AND WOULD LIKE TO GET PINGED ON ANY NEW ESCALATIONS." CUSTOMER PROBLEM: K - SYNAPSYS LOCKED INTO CULTURES - OVER 70. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: DID NOTICE THAT THE BACKUP SERVER MEMORY WAS AT 72% USED. DISPATCH PRIORITY DETERMINATION: Q1 ABLE TO PROCESS SAMPLES (Y/N)? Y. Q2 ABLE TO MAINTAIN WORKFLOW(Y/N)? N. PRIORITY: EMERGENCY. IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE OVER 70 SAMPLES LOCKED IN SYNAPSYS. CUSTOMER CALLED TO SAY THAT THERE WERE OVER 70 SAMPLES LOCKED IN SYNAPSYS. THESE 70 WERE LOCKED FOR GREATER THAN THE 4 HOUR LOCK WINDOW. I LOGGED INTO THE BACKUP SERVER AND NOTICED THAT THERE WERE SOME FAILED WINDOWS UPDATES AS WELL AS OVER 70 PERCENT MEMORY WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171453 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS) 00382904441500

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown