BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 14250011 · Received April 29, 2022

    Report

    Report Number
    14250011
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    February 13, 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

    TABLO RUN STARTED IN EVENING, ABOUT 30 MINUTES LATER FIRST ALARM WENT OFF STATING BYPASS VALVE FAILURE AND INSTRUCTED US TO PRESS AND RELEASE THE POWER BUTTON TO RESTART. AFTER FOLLOWING THOSE INSTRUCTIONS NEW ALARM OF "BAD DIALYSATE CONDUCTIVITY" APPEARED AND INSTRUCTED US THAT THE TREATMENT MUST END AND THE BLOOD TO BE DISCARDED AND TO NOT MANUALLY RETURN THE BLOOD. FOLLOWING TEAR DOWN A THIRD ALARM APPEARED ON THE SCREEN THAT TABLO REQUIRES TECHNICAL SUPPORT AND TO CALL OUTSET TECHNICAL SUPPORT CALLED OUTSET TECHNICAL SUPPORT. SHE RECOMMENDED SWITCHING OUT THE MACHINE AS SHE COULDN'T SEE ANYTHING ON HER END THAT WOULD RESULT IN THE ALARMS. SHE ALSO ESTIMATED THE PATIENT BLOOD LOSS TO 122ML WILL REVIEW TABLO TEAM MEETING.

    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
    57590 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17520 DA Male