BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERANOVA 400

    MDR report key: 22955575 · Received September 3, 2025

    Report

    Report Number
    MW5175586
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 27, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BAXTER/VANTIVE US HEALTHCARE LLC.
    Product Code
    QAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2ND REPORT - SAME ISSUE WAS EXPERIENCED BY 2 PATIENTS ON SAME DAY WITH SAME PRODUCT BLOOD CLOTTED DURING DIALYSIS TREATMENT. WHILE ATTEMPTING TO RINSE BACK THE PATIENTS¿ BLOOD THE FIBERS INSIDE THE DIALYZER BROKE OPEN AND WE HAD A "BLOOD IN DIALYSATE" ALARM. BLOOD WAS NOT ABLE TO BE RETURNED TO PATIENT CAUSING A LOSS OF 300ML. RN WAS NOTIFIED. NEW MACHINE WAS STARTED AND TREATMENT WAS RESTARTED ON NEW MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131567 THERANOVA 400 HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE QAX BAXTER/VANTIVE US HEALTHCARE LLC. 4-6901-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other