BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO(R) HEMODIALYSIS SYSTEM

    MDR report key: 13994640 · Received April 4, 2022

    Report

    Report Number
    13994640
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    February 2, 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 RUNNING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH TABLO. CHARGE NURSE WALKED BY PT'S ROOM AND NOTICED A PUDDLE OF BLOOD BELOW THE TABLO MACHINE. NO ALARMS WERE ON. THE TOP CONNECTION ON THE FILTER WORKED ITSELF LOOSE AND WAS SPILLING BLOOD. MEDICAL ICU RESIDENT WAS NOTIFIED. TABLO WAS DISCONTINUED AND A COMPLETE BLOOD COUNT WAS ORDERED AND DRAWN 1 HOUR AFTER INCIDENT AND NO SIGNIFICANT CHANGES IN HEMOGLOBIN WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493150 TABLO(R) HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Male