BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERANOVA

    MDR report key: 23415685 · Received October 29, 2025

    Report

    Report Number
    9611369-2025-00181
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 15, 2025
    Report Date
    December 3, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    QAX
    UDI-DI
    07332414125721
    PMA / PMN Number
    DEN190042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: REPORTED AS "ADULT". THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3, B5, D2A, D2B, D4, G4, H4, H6, AND H11. B5: UPON FOLLOW UP, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAROXYSMAL COUGHING, BACK PAIN, AND CYANOSIS TO LIPS AND ORAL MUCOUS MEMBRANES. THE PATIENT WAS TRANSPORTED FOR EVALUATION VIA EMS (EMERGENCY MEDICAL SERVICES). IT WAS REPORTED THAT THE PATIENT RECEIVED "MEDICAL TREATMENT ON DIALYSIS". H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT WITH AN UNSPECIFIED THERANOVA DIALYZER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN. IT WAS FURTHER REPORTED THAT THIS WAS THE FIRST TIME THE PATIENT HAD USED A THERANOVA DIALYZER. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ACCORDING TO THE REPORTER, THE ¿SYMPTOMS RESOLVING AFTER ENDING THERAPY¿. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719183 THERANOVA HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE QAX VANTIVE US HEALTHCARE LLC NA 4-6926-H-01 07332414125721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| O NI.