BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 14249912 · Received April 29, 2022

    Report

    Report Number
    14249912
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    January 14, 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

    PATIENT¿S MOTHER REPEATED ENTRY/EXITS INTO ROOM INTERRUPTED TREATMENT DEVICE TROUBLESHOOTING BY CAUSING STAFF TO STOP TROUBLESHOOTING SO THAT PATIENT COULD ENTER/EXIT THE ROOM. PATIENT WAS EXPERIENCING HIGH % TRACH LEAK CAUSING DESATURATION AND EXPERIENCING TABLO TREATMENT TUBING OBSTRUCTION CAUSING INTERRUPTION OF HD. REPEATED ENTRY AND EXIT INTO PATIENT'S ROOM WHILE TROUBLESHOOTING DEVICES COULD HAVE CAUSED PATIENT DETERIORATION RELATED TO DEVICE ISSUES AND/OR DISLODGING OF IV/AIRWAY EQUIPMENT FROM MOVING DEVICES TO LET MOTHER IN AND OUT. SINCE MOTHER VOLUNTARILY LEFT ROOM WHILE ISSUES WERE ACTIVELY BEING TROUBLESHOOTED, STAFF ASKED THAT PATIENT MOTHER AWAIT OUTSIDE OF UNIT UPON TRYING TO REENTER WHILE THE ISSUES WITH PATIENT DEVICES WERE ADDRESSED AND SOLVED AND PATIENT BECAME STABLE. VISITOR SHOULD RECEIVE INSTRUCTION ON THE POTENTIAL SAFETY ISSUES CAUSED BY REPEATED EXIT/ENTRY DURING STAFF TROUBLESHOOTING AND DURING PATIENT DETERIORATION.

    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
    109500 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA Female