BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO(R) HEMODIALYSIS SYSTEM

    MDR report key: 14013680 · Received April 5, 2022

    Report

    Report Number
    14013680
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 9, 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

    NO EQUIPMENT ISSUES OR HUMAN FACTORS INTERACTING WITH EQUIPMENT IDENTIFIED.

    Description of Event or Problem · 0

    PT WAS ON TABLO WITH 5 HOURS REMAINING WHEN NURSE GOT HIGH ARTERIAL PRESSURE ALARMS. NURSE NOTICED THAT THE ARTERIAL LINE ATTACHED TO TABLO WAS FILLED WITH CLOTS. TRANSMEMBRANE PRESSURES WITHIN THE 90S. BLOOD RETURNED AND WHEN ATTEMPTING TO DRAIN THE DIALYZER, MACHINE KEPT ALARMING TO UNCLAMP THE YELLOW CLAMP. THE CLAMP WAS OPEN AND THE TABLO HELP LINE WAS CONTACTED. NURSE WAS UNABLE TO GET A HOLD OF ANYONE AND WAS TOLD TO LEAVE A MESSAGE. SITE TABLO REPRESENTATIVE WAS CALLED DIRECTLY AND INSTRUCTED TO TURN OFF AND POWER BACK ON MACHINE AND TRY AGAIN. THIS RESOLVED THE ISSUE. LATER WHEN THE RUN WAS COMPLETED AND TABLO WAS DISCONNECTED THE MACHINE GAVE A MESSAGE TO CALL TECHNICAL SUPPORT. BEFORE NURSE COULD CALL, THE MESSAGE DISAPPEARED, AND A HEAT CYCLE WAS COMPLETED. THE ALARM: SALINE CLAMP MEDIUM DID NOT HAPPEN UNTIL AFTER A NEW SALINE BAG WAS REQUIRED AND CHANGED OUT. 10 MINUTES LATER THE MACHINE STARTED ALARMING SALINE CLAMP MEDIUM. IT IS UNKNOWN WHAT POTENTIAL HARM THERE IS WHEN POWERING OFF A MACHINE THAT IS CONNECTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78796 TABLO(R) 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