BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERANOVA

    MDR report key: 18194785 · Received November 22, 2023

    Report

    Report Number
    9611369-2023-00247
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 1, 2023
    Report Date
    December 26, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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

    H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPHS WERE REVIEWED, AND IT WAS NOTED THAT THE PICTURES DID NOT SHOW ANYTHING RECOGNIZABLE AND THEREFORE NO DETAILED INVESTIGATION COULD BE PERFORMED. DUE TO THE ABSENCE OF AN ACTUAL SAMPLE THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, ONE UNIT OF THERANOVA 400 HAD AN EXTERNAL FLUID LEAKAGE. 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
    2027373 THERANOVA HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE QAX BAXTER HEALTHCARE CORPORATION NA 3-6954-H-01 07332414122904

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.