BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERANOVA

    MDR report key: 23949955 · Received January 2, 2026

    Report

    Report Number
    9611369-2026-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 8, 2025
    Report Date
    January 30, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    QAX
    UDI-DI
    07332414122904
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 DID NOT IDENTIFY ANY PRODUCT ABNORMALITY THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAKAGE. 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 LEAK 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM A THERANOVA 400 DURING HEMODIALYSIS THERAPY, DESCRIBED AS "THE MEMBRANE WAS BROKEN". 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
    3571 THERANOVA HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE QAX VANTIVE US HEALTHCARE LLC NA 5-9910-H-01 07332414122904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown