BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE PACS

    MDR report key: 10388578 · Received August 10, 2020

    Report

    Report Number
    3004972322-2020-00002
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    May 22, 2020
    Report Date
    January 20, 2021
    Manufacturer
    FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
    Product Code
    LLZ
    UDI-DI
    00854904006008
    PMA / PMN Number
    K160108
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION IS PROVIDED IN SECTION H7, H9, AND H10 (ADDITIONAL NARRATIVE). FUJIFILM INITIATED A RECALL ON 9/11/2020 TO CORRECT THE SUV ISSUE BY PROVIDING A SOFTWARE UPGRADE TO SYNAPSE PACS 5.7.200US. C&R REPORT (1000513161-09/17/2020-001-C) WAS SUBMITTED TO THE FDA. ON 01/16/2021, THE RECALL WAS CLASSIFIED BY FDA AS CLASS II AND ASSIGNED THE RECALL NUMBER Z-0878-2021. NO FURTHER INVESTIGATION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS EVALUATED AND REPLICATED IN THE FMSU LAB. THE CAUSE WAS TRACED TO INSUFFICIENT TESTING DURING DEVELOPMENT. A BUG FIX IS BEING DEVELOPED AND AFFECTED CUSTOMERS WILL BE NOTIFIED AND PROVIDED THE FIX. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INTERNAL COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, FUJIFILM MEDICAL SYSTEMS USA, INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE PACS STANDARD UPTAKE VALUES (SUV). ON (B)(6) 2020, FMSU ENGINEERING DEPARTMENT INITIATED A BUG FOR THE ISSUE TO INVESTIGATE THE RISK TO PATIENT SAFETY. ON (B)(6) 2020, ENGINEERING DEPARTMENT FOUND THAT THE MAX SUV VALUES WERE DIFFERENT WHEN USING 2D REGION OF INTEREST (ROI) AS COMPARED TO WHEN USING 3D SPHERE ROI. VALUES ARE USED TO DETERMINE THE SIZE OF THE LESIONS AND CONTRIBUTE TO A DIAGNOSIS. THE ISSUE WAS FOUND TO ONLY IMPACT THE VALUES WHEN USED WITH A SPECIFIC NON-FUJIFILM DEVICE FOR PET CALCULATIONS. THERE WAS NO PATIENT SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849411 SYNAPSE PACS SYNAPSE PACS LLZ FUJIFILM MEDICAL SYSTEMS U.S.A., INC. N/A N/A 00854904006008

    Patients

    Seq Age Sex Outcome Treatment
    1 SIEMENS PET