BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MUL-T-PAD

    MDR report key: 23073093 · Received September 17, 2025

    Report

    Report Number
    23073093
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 11, 2025
    Manufacturer
    C2DX, INC.
    Product Code
    ILO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    S: NEW FLUID WARMER (T/PUMP) GREEN PAD LEAKED . B: PT IS USING T/PUMP AND PAD TO WARM BLOOD FOR DIALYSIS USING AQUADEX MACHINE. CHANGED WATER AND PAD OUT AS IT WAS UNCLEAR WHENT IT WAS LAST CHANGED OUT. A: WATER CHANGED AND NEW PAD ATTACHED, AS WATER TURNED ON WATER LEAKED OUT OF THE PAD. THERE IS/ARE HOLES IN THE PAD. UNABLE TO FIND HOLE(S). CHANGED OUT PAD FOR ANOTHER NEW PAD AND NO LEAKAGE. C2DX: REF 8002-062-022, LOT 300547424.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599223 MUL-T-PAD PACK, HOT OR COLD, WATER CIRCULATING ILO C2DX, INC. 8002-062-022 300547424

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male