BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 14249885 · Received April 29, 2022

    Report

    Report Number
    14249885
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    November 18, 2021
    Report Date
    April 19, 2022
    Manufacturer
    OUTSET MEDICAL, INC
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TABLO ALARMING TO CHECK RED AND YELLOW SALINE CLAMP DUE TO ERROR. CLAMPS WERE CHECKED AND OPEN. ALARMS CONTINUED AND WE WERE UNABLE TO RETURN THE BLOOD. NURSING MANAGER CONTACTED WHO CONTACTED TABLO COORDINATOR. TABLO COORDINATOR IS REACHING OUT TO OUTSET. PATIENT IS A COVID PATIENT AND DOES HAVE HEPARIN INFUSING AT 1300 UNITS/HR."

    Description of Event or Problem · 0

    NO EQUIPMENT ISSUES OR HUMAN FACTORS INTERACTING WITH EQUIPMENT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119110 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male