BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 14249952 · Received April 29, 2022

    Report

    Report Number
    14249952
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    January 14, 2022
    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

    PATIENT IS ON TABLO DT TO AKF. THE TABLO CONTINUED TO CLOT OFF AND SYSTEM WAS CHANGED MULTIPLE TIMES. PATIENT WAS PLACED ON HEPARIN GTT. AND ORDER WAS PLACED TO FLUSH TABLO SYSTEM EVERY HOUR TO PREVENT IT FROM CLOTTING. NIGHT RN DID NOT FLUSH SYSTEM BUT INSTEAD BOLUSED THE PATIENT EVERY HOUR. FLUSHES ARE CALCULATED IN I/O AND REMOVED WHILE BOLUSES ARE NOT. PATIENT ENDED UP RECEIVING 1.2L OF FLUID THAT WAS NOT ACCOUNTED FOR DURING DIALYSIS FLUID REMOVAL. PROVIDER WAS NOTIFIED AND CHANGES ARE BEING MADE TO FLUID REMOVAL GOAL. PATIENT ADMITTED FOR PRES, DEVELOPED ARDS AND ARF WHILE HOSPITALIZED. SHE REQUIRED TRACH AND TABLO. RN MAY NOT HAVE UNDERSTOOD THE DIFFERENCE BETWEEN FLUSHES AND BOLUSES ON TABLO CLARIFYING WITH STAFF REGARDING THE DIFFERENCE.

    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
    212746 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA Female