BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUASMART CONTINUOUS RENAL REPLACEMENT THERAPY AND HEMODIALYSIS DEVICES

    MDR report key: 22898112 · Received August 26, 2025

    Report

    Report Number
    MW5175264
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Report Date
    August 19, 2025
    Manufacturer
    MEDICA S.P.A.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING USE, THERE WAS A PRESSURE ALARM AND A BLOOD ALARM. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380383 EQUASMART CONTINUOUS RENAL REPLACEMENT THERAPY AND HEMODIALYSIS DEVICES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MEDICA S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown