BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO(R) HEMODIALYSIS SYSTEM

    MDR report key: 13051595 · Received December 21, 2021

    Report

    Report Number
    13051595
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 11, 2021
    Report Date
    December 16, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS UNDERGOING HEMODIALYSIS WHEN THE TABLO HAD A WATER MODULE FAILURE. THE TABLO INSTRUCTED THE USER TO RINSE THE PATIENT BACK, WHICH WAS DONE. THE MODULE WAS CHANGED OUT, AND THE FAILURE OCCURRED AGAIN. THE USER CALLED TABLO. TABLO ATTEMPTED TO REMOTELY TROUBLESHOOT. WHILE THIS WAS OCCURRING, THE USER SMELLED SMOKE. THE DEVICE WAS DISCONNECTED AND SHUT OFF. ANOTHER TABLO WAS OBTAINED, AND THE PATIENT'S HEMODIALYSIS WAS COMPLETED WITHOUT FURTHER INCIDENT. NO UNTOWARD PATIENT EFFECTS. MANUFACTURER RESPONSE FOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM, TABLO(R) HEMODIALYSIS SYSTEM (PER SITE REPORTER). OUTSET MEDICAL CAME TO FACILITY TO EVALUATE THE TABLO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955072 TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0006000

    Patients

    Seq Age Sex Outcome Treatment
    1 33215 DA Male