BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPSE CARDIOVASCULAR

    MDR report key: 11159001 · Received January 13, 2021

    Report

    Report Number
    3004972322-2021-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 2, 2020
    Report Date
    June 10, 2021
    Product Code
    LLZ
    UDI-DI
    00854904006015
    PMA / PMN Number
    K151859
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM INITIATED A RECALL ON (B)(6) 2021 TO ALERT CUSTOMERS OF THE PATIENT ID ISSUES EXISTING IN SYNAPSE CV 6 USERS WITH ADVANCED REPORTING. FUJIFILM SUBMITTED C&R REPORT (1000513161-05/05/2021-001-C) TO THE FDA, WHICH WAS CLASSIFIED AS CLASS II AND ASSIGNED RECALL NUMBER Z-1775-2021 ON 06/02/2021. NO FURTHER INVESTIGATION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: UNKNOWN. THE ISSUE WAS EVALUATED AND REPLICATED IN THE FMSU LAB; THE CAUSE WAS TRACED TO A SOFTWARE CONFIGURATION. THIS ISSUE IS VERY RARE AND REQUIRES MANY TRIES WITH LARGE STUDIES TO REPRODUCE; IT IS CONSIDERED TO BE A VERY RARE OCCURRENCE IN A CLINICAL ENVIRONMENT. THE NUMERIC ID ASSIGNED TO A PATIENT RECORD COULD BE REUSED ONCE A NEWER PATIENT RECORD WAS MERGED TO AN OLDER PATIENT RECORD. WHEN THIS ACTION IS DONE, THE NEWER ID IS MADE AVAILABLE AGAIN. THIS WAS NOT AN ISSUE PRIOR TO ADVANCED REPORTING. WITH THE INTRODUCTION OF ADVANCED REPORTING THE NUMERIC ID IS NOT RELEASED WITHIN THE ADVANCED REPORTING DATABASE SCHEMA AND THAT IS HOW THE MISMATCH BETWEEN THE PATIENT DEMOGRAPHIC DATA CAN OCCUR. REF: INTERNAL COMPLAINT NUMBER COMP (B)(4).

    Description of Event or Problem · 1

    ON DECEMBER 02, 2020 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. (FMSU) SERVICE DEPARTMENT RECEIVED A CUSTOMER INQUIRY FOR ASSISTANCE WITH SYNAPSE CARDIOVASCULAR. STUDY WAS SENT IN FOR A NEW PATIENT WITH THE CORRECT MRN. INCORRECT MRN IS SHOWING IN CV CLIENT. ON DECEMBER 16, 2020, A RISK ASSESSMENT WAS PERFORMED TO INVESTIGATE THE RISK TO PATIENT SAFETY. THERE WAS NO PATIENT IMPACT, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THIS EVENT. THE ISSUE IS CONSIDERED HIGHLY DETECTABLE BY A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61145 SYNAPSE CARDIOVASCULAR SYNAPSE CV LLZ N/A N/A 00854904006015

    Patients

    Seq Age Sex Outcome Treatment
    1