BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX

    MDR report key: 22457720 · Received July 9, 2025

    Report

    Report Number
    9611369-2025-00092
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 7, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FJI
    UDI-DI
    07332414086633
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION D9, H3, H6, H11. H11: THE DEVICE WAS RECEIVED, AND PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. VISUAL INSPECTION OF THE ACTUAL SAMPLE SHOWED THE BLOOD PROTECTION CAPS ATTACHED TO THE DIALYSATE PORTS. THESE DIALYZER CONNECTORS WERE EVALUATED WITH NO ISSUES NOTED. FUNCTIONAL TESTING WAS PERFORMED ON BOTH THE DEVICE DIALYSATE AND BLOOD SIDES, AND NO LEAKS WERE OBSERVED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRIMING OF A POLYFLUX DIALYZER, AN EXTERNAL LEAK WAS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702692 POLYFLUX DIALYZER, CAPILLARY, HOLLOW FIBER FJI VANTIVE US HEALTHCARE LLC NA 4-5134-H-01 07332414086633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.