BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO

    MDR report key: 14249830 · Received April 29, 2022

    Report

    Report Number
    14249830
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    January 25, 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

    STOPPING THE CRRT RUN ON THE PT. AND PREPARING TO RETURN THE BLOOD TO THE PT. AND THE SCREEN TURNED BLACK AND AN UNKNOWN ALERT OF "UNFORTUNATELY, SEQUOIA GUI HAS STOPPED" AND THE MACHINE SHUTDOWN, REQUIRING THE NURSE TO MANUALLY RETURN THE BLOOD TO THE PATIENT. THE MACHINE WAS TAKEN DOWN TO THE STORE ROOM. THERE IT WAS PLUGGED IN AND CONNECTED TO THE WATER AND THE OUTPUT DRAIN. THE SCREEN ON THE MACHINE INDICATED THAT THE COMPANY SHOULD BE CALLED FOR SERVICE. I CALLED THE COMPANY AND NOTIFIED THE REPRESENTATIVE OF THE EVENT. HE ATTEMPTED TO REMOTE IN AND WAS UNABLE TO. HE WAS STILL ABLE TO RUN REPORTS. HE INSTRUCTED ME TO GO AHEAD AND RUN A HEAT CLEAN. I SET THE PUMP FOR A HEAT CLEAN. A CASE NUMBER OF WAS ASSIGNED AND I WAS INSTRUCTED TO TAG THE MACHINE AS OUT OF SERVICE. I THEN EMAILED ALL THE INDIVIDUALS THAT ARE ATTENDING THE DAILY TABLO TOUCHBASE MEETINGS." I WAS ON THE PHONE WITH THE REPRESENTATIVE FOR APPROXIMATELY 30 MINUTES WITH THE MACHINE. THIS DID NOT TAKE INTO ACCOUNT THE TIME IT TOOK TO GET THE MACHINE DOWN TO THE STORE ROOM, HOOK IT UP AND RUN THE HEAT CLEAN. IF I HAD NOT BEEN WORKING, THE CHARGE NURSE OR OTHER STAFF NURSE WOULD HAVE HAD TO DEAL WITH THIS AND BE OFF THE FLOOR FOR AN EXTENDED PERIOD OF TIME.

    Description of Event or Problem · 0

    STOPPING THE CRRT RUN ON THE PT. AND PREPARING TO RETURN THE BLOOD TO THE PT. AND THE SCREEN TURNED BLACK AND AN UNKNOWN ALERT OF "UNFORTUNATELY, SEQUOIA GUI HAS STOPPED" AND THE MACHINE SHUTDOWN, REQUIRING THE NURSE TO MANUALLY RETURN THE BLOOD TO THE PATIENT. THE MACHINE WAS TAKEN DOWN TO THE STORE ROOM . THERE IT WAS PLUGGED IN AND CONNECTED TO THE WATER AND THE OUTPUT DRAIN. THE SCREEN ON THE MACHINE INDICATED THAT THE COMPANY SHOULD BE CALLED FOR SERVICE. I CALLED THE COMPANY AND NOTIFIED THE REPRESENTATIVE OF THE EVENT. HE ATTEMPTED TO REMOTE IN AND WAS UNABLE TO. HE WAS STILL ABLE TO RUN REPORTS. HE INSTRUCTED ME TO GO AHEAD AND RUN A HEAT CLEAN. I SET THE PUMP FOR A HEAT CLEAN. A CASE NUMBER OF WAS ASSIGNED AND I WAS INSTRUCTED TO TAG THE MACHINE AS OUT OF SERVICE. I THEN EMAILED ALL THE INDIVIDUALS THAT ARE ATTENDING THE DAILY TABLO TOUCHBASE MEETINGS." I WAS ON THE PHONE WITH THE REPRESENTATIVE FOR APPROXIMATELY 30 MINUTES WITH THE MACHINE. THIS DID NOT TAKE INTO ACCOUNT THE TIME IT TOOK TO GET THE MACHINE DOWN TO THE STORE ROOM, HOOK IT UP AND RUN THE HEAT CLEAN. IF I HAD NOT BEEN WORKING, THE CHARGE NURSE OR OTHER STAFF NURSE WOULD HAVE HAD TO DEAL WITH THIS AND BE OFF THE FLOOR FOR AN EXTENDED PERIOD OF TIME.

    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
    98750 TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown