BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO

    MDR report key: 14249884 · Received April 29, 2022

    Report

    Report Number
    14249884
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    November 17, 2021
    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

    S: MALFUNCTION OF TABLO - BREAKAGE/BLEEDING WITHIN CARTRIDGE DURING BLOOD RETURN. B: PATIENT ON TABLO WITH MULTIPLE REPETITIVE ALARMS, MACHINE WOULD NOT CONTINUE. ATTEMPTED TO HAVE MACHINE RETURN BLOOD, BUT MACHINE WOULD NOT, MORE ALARMS. JUST PRIOR TO 7 MINUTES WE ATTEMPTED TO HAND CRANKED BLOOD BACK TO PATIENT, BLOOD LEAKAGE NOTED IN CARTRIDGE/MACHINE DURING HAND CRANKING. A: IT WAS BROUGHT TO MY ATTENTION AFTER THE FACT THAT WE DID NOT TURN THE LOCKS PRIOR TO HAND CRANKING BLOOD BACK TO PATIENT. TIME WAS RUNNING OUT FOR BLOOD RETURN, SO IT WAS DONE QUICKLY WITHOUT CONSULTING THE MANUAL. UNKNOWN IF THIS MAY HAVE CONTRIBUTED TO BREAKAGE OF THE CARTRIDGE. R: RE-EDUCATE ON PROCESS OF BLOOD RETURN, AND/OR ASSESS TABLO MACHINE/CARTRIDGE FOR FUNCTIONALITY. TIME WAS SHORT, STRESS LEVELS HIGH, THE MACHINE CLEARLY NOT FUNCTIONING. I WAS THE CHARGE RN ADMITTING MY SECOND COVID PATIENT AND DID NOT THINK TO CONSULT THE MANUAL WHEN CALLED INTO THIS ROOM TO ASSIST WITH A MALFUNCTIONING TABLO MACHINE. NO TABLO REPS OR ASSISTANTS WERE IN HOUSE, THE CLOCK WAS TICKING ON THE 7 MINUTE TO RETURN BLOOD TO OUR PATIENT WHO WAS MAXED ON EPI, LEVO, VASO.

    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
    119109 TABLO DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Female