BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 19538045 · Received June 14, 2024

    Report

    Report Number
    19538045
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    February 20, 2024
    Report Date
    June 13, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MACHINE WAS FOUND PRESENTING SMOKE AND FLAMES - WHILE NOT IN USE, AND IN STORAGE. IT WAS QUICKLY UNPLUGGED AND DISCONNECTED FROM THE WALL, AS WELL AS PLACED IN A SAFE LOCATION. MANUFACTURER RESPONSE FOR HEMODIALYSIS MACHINE, TABLO (PER SITE REPORTER). "FOLLOWING AN EXTENSIVE EXAMINATION OF THE CONSOLE, IT BECAME EVIDENT THAT A LEAK HAD OCCURRED INSIDE THE UNIT. THIS LEAK PRECIPITATED A SHORT CIRCUIT AND CONSEQUENTIAL DAMAGE TO A BOARD WITHIN THE SYSTEM. IN RESPONSE, WE ARE TAKING NECESSARY STEPS TO ADDRESS THE SITUATION. SPECIFICALLY, WE ARE IN THE PROCESS OF ORDERING NEW CABLES AND BOARDS TO REPLACE THOSE THAT WERE IMPACTED BY THE LEAK. THIS PROACTIVE APPROACH ENSURES THAT WE WILL BE ABLE TO SWIFTLY REPAIR AND RESTORE THE CONSOLE TO FULL FUNCTIONALITY IN THE SHORTEST POSSIBLE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184045 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE KDI OUTSET MEDICAL, INC. PN-0006000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown