BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERANOVA

    MDR report key: 22709289 · Received August 4, 2025

    Report

    Report Number
    9611369-2025-00114
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 11, 2025
    Report Date
    August 21, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    FJI
    UDI-DI
    07332414122904
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H11. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED FLUID DROPLETS ORIGINATING FROM THE DIALYZER HEADER AREA. THE SPECIFIC DEFECT THAT ALLOWED THE LEAKAGE WAS NOT VISIBLE. 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 VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED AS NO FURTHER OR ACTUAL SAMPLE TESTING COULD BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM THE SEALING OF THE HEADER OF A THERANOVA 400 DURING HEMODIALYSIS THERAPY IN THE INTENSIVE CARE UNIT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2448849 THERANOVA DIALYZER, CAPILLARY, HOLLOW FIBER FJI VANTIVE US HEALTHCARE LLC NA 4-6968-H-01 07332414122904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown