BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIROS DELIVERY SET

    MDR report key: 22878233 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00020
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    November 8, 2024
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LTD
    Product Code
    IWJ
    UDI-DI
    00850014612023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE-RELATED DEATH OR SERIOUS INJURY WAS REPORTED. THE IFU AND TRAINING MANUAL STATE TO ENSURE AIR IS REMOVED FROM THE LINES AND SPECIFICALLY TO ENSURE THE WET TO WET CONNECTION ON THE C-LINES TO PREVENT AIR FROM BEING INTRODUCED. A REVIEW OF PRODUCTION RECORDS SHOW THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATIONS AND MET ALL QUALITY ASSURANCE CRITERIA. A RETROSPECTIVE MDR HAS BEEN FILED DUE TO THIS POTENTIAL FOR SERIOUS INJURY AS THERE IS A POTENTIAL RISK OF AIR EMBOLISM SHOULD THE LINES NOT BE PROPERLY FLUSHED.

    Description of Event or Problem · 0

    THERE WAS A SIGNIFICANT COLUMN OF AIR THAT CAME OUT OF THE D VIAL DURING THE FIRST ALIQUOT OF THE ADMINISTRATION, SPECIFICALLY FROM THE C-LINE CONNECTIONS. THE LINES WERE FLUSHED WITH APPROX. 40 CCS OF D5W PRIOR TO ADMINISTRATION. PHYSICIAN WOULD LIKE TO KNOW WHERE THE AIR IS COMING FROM, INSIDE THE D-VIAL OR IS THERE AN ISSUE WITH THE DELIVERY SETS. IS IT POSSIBLE TO LOOK AT FLUSHING THE D-LINE AND C-LINE INDEPENDENTLY? I SUSPECT THAT THE AIR HAS SOMETHING TO DO WITH THE RED CONNECTOR PIECE, I HAVE NOTICED THAT IT IS LOOSE AND NOT SECURE DURING THE PRIMING PROCESS AND THE LINES BECOME DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2667719 SIROS DELIVERY SET System, applicator, radionuclide, manual IWJ SIRTEX MEDICAL PTY LTD SIR-10300 1142008 00850014612023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown