BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYNAPSYS¿

    MDR report key: 16390723 · Received February 16, 2023

    Report

    Report Number
    1119779-2023-00151
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 31, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION OF A COMPLAINT INVOLVING SYNAPSYS PRODUCT NUMBER 444150, SERIAL NUMBER SL01099. ACCORDING TO INFORMATION PROVIDED, DATA WAS NOT SYNCING PROPERLY BETWEEN THE BACTEC INSTRUMENTS AND SYNAPSYS. NO OTHER ISSUES WERE REPORTED. DURING INVESTIGATION, BD SERVICE PERSONNEL FOUND APPROXIMATELY 250 MESSAGES IN THE 'QUEUE MESSAGES' TABLE. TO ADDRESS THIS SITUATION, THE INSTRUMENT ADAPTER AND SYNAPSYS SERVICES WERE RESTARTED. AFTER THIS ACTION, SUCCESSFUL TRANSMISSION TO LIS WAS VERIFIED AND THE SYNC ISSUE WAS RESOLVED. ALTHOUGH THE ROOT CAUSE OF THIS SITUATION WAS NOT DETERMINED, THERE WAS NO SPECIFIC INDICATION OF ANY ASSOCIATED SYNAPSYS PRODUCT QUALITY ISSUE OR MALFUNCTION. BASED ON THESE FINDINGS, THIS CASE HAS BEEN ASSESSED AS UNCONFIRMED. REVIEW FOUND COMPLAINTS OF THIS TYPE WERE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY. ADDITIONALLY, NO ADVERSE TREND WAS IDENTIFIED FOR REPORTS OF THIS TYPE. DEVICE HISTORY RECORD REVIEW WAS NOT APPLICABLE AS THIS IS A STANDALONE SOFTWARE PRODUCT AND THE OPERATION/ FUNCTIONALITY OF THIS TYPE OF PRODUCT IS CONFIRMED AT THE TIME OF INSTALLATION. REPORTS OF THIS TYPE WILL CONTINUE TO BE MONITORED. HOWEVER, AS THERE IS NO EVIDENCE OF ANY NEW ADVERSE TREND, HAZARD OR RISK, NO ADDITIONAL ACTION IS CURRENTLY INDICATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD SYNAPSYS¿ THAT THERE WAS AN APPLICATION ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALL DATA REGARDING VIAL STATUSES IN THE CONNECTED BACTEC FX INSTRUMENTS IS SYNCED TO SYNAPSYS. FOR EXAMPLE SOME OF THE GROWTH RESULTS AND NEW VIALS SCANNED INTO BACTECS DO NOT SHOW IN THE SYNAPSYS REPORTS AND ARE NOT EITHER COMMUNICATED TO LIS. THIS IS CAUSING POSITIVE BLOOD CULTURE TO BE POTENTIALLY MISSED. SOME OF THE VIAL DATA IS STILL SYNCED. THERE IS NO ERROR MESSAGE VISIBLE ANYWHERE IN SYNAPSYS OR IN BACTECS TO INDICATE THERE IS AN ERROR CONDITION PRESENT MAKING THE ISSUE DIFFICULT FOR THE USER TO DETECT AND IT TOOK OVER A DAY FOR THEM TO NOTICE THE ERROR CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD SYNAPSYS¿ THAT THERE WAS AN APPLICATION ERROR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALL DATA REGARDING VIAL STATUSES IN THE CONNECTED BACTEC FX INSTRUMENTS IS SYNCED TO SYNAPSYS. FOR EXAMPLE SOME OF THE GROWTH RESULTS AND NEW VIALS SCANNED INTO BACTECS DO NOT SHOW IN THE SYNAPSYS REPORTS AND ARE NOT EITHER COMMUNICATED TO LIS. THIS IS CAUSING POSITIVE BLOOD CULTURE TO BE POTENTIALLY MISSED. SOME OF THE VIAL DATA IS STILL SYNCED. THERE IS NO ERROR MESSAGE VISIBLE ANYWHERE IN SYNAPSYS OR IN BACTECS TO INDICATE THERE IS AN ERROR CONDITION PRESENT MAKING THE ISSUE DIFFICULT FOR THE USER TO DETECT AND IT TOOK OVER A DAY FOR THEM TO NOTICE THE ERROR CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385391 BD SYNAPSYS¿ NA JQP BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown