BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 14249826 · Received April 29, 2022

    Report

    Report Number
    14249826
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    January 14, 2022
    Report Date
    April 22, 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 ON TABLO WENT TO PRINT PATIENT TABLO REPORT AFTER RUN. UNABLE TO LOCATE PATIENT. ASSESSED MACHINE ONCE HEAT WAS FINISHED, MACHINE NOT CONNECTED TO WI-FI CONTACTED PERSONNEL, NOT ABLE TO CONNECT TO WI-FI. WENT TO TUB ROOM TO SWITCH OUT DEVICES ONLY MACHINE IN ROOM WAS CURRENTLY DOING A FULL CHEM. AMANDA THEN GAVE FURTHER INSTRUCTIONS TO SWITCH OUT THE KEYS AND TABLO DEVICE WITH ONE OF THE TABLO DEVICES FOR HD IN INFUSION CENTER HOWEVER, IT MADE THE MACHINE UNABLE TO SETUP ONCE KEY EXCHANGE. CHANGED KEY TO ORIGINAL KEY WHICH ALLOWED NEW MACHINE TO WORK AND SWITCHED OUT MACHINES WHILE GOING OVER LIMITS AND CHANGES THAT WERE NEEDED TO BE MADE ON DEVICE ON THE PHONE.

    Description of Event or Problem · 0

    NO EQUIPMENT ISSUES OR HUMAN FACTORS INTERACTING WITH EQUIPMENT IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT ON TABLO WENT TO PRINT PATIENT TABLO REPORT AFTER RUN. UNABLE TO LOCATE PATIENT. ASSESSED MACHINE ONCE HEAT WAS FINISHED, MACHINE NOT CONNECTED TO WI-FI CONTACTED PERSONNEL, NOT ABLE TO CONNECT TO WI-FI. WENT TO TUB ROOM TO SWITCH OUT DEVICES ONLY MACHINE IN ROOM WAS CURRENTLY DOING A FULL CHEM. SHE THEN GAVE FURTHER INSTRUCTIONS TO SWITCH OUT THE KEYS AND TABLO DEVICE WITH ONE OF THE TABLO DEVICES FOR HD IN INFUSION CENTER HOWEVER, IT MADE THE MACHINE UNABLE TO SETUP ONCE KEY EXCHANGE. CHANGED KEY TO ORIGINAL KEY WHICH ALLOWED NEW MACHINE TO WORK AND SWITCHED OUT MACHINES WHILE GOING OVER LIMITS AND CHANGES THAT WERE NEEDED TO BE MADE ON DEVICE ON THE PHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98746 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14600 DA Female