BEUDAMED
    FDA Adverse Event Death Summary report: N

    Tablo(R) Hemodialysis System

    MDR report key: 10036731 · Received May 7, 2020

    Report

    Report Number
    3010355846-2020-00017
    Event Type
    Death
    Date Received
    May 7, 2020
    Date of Event
    March 27, 2020
    Report Date
    May 7, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K160866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. NO RELATED SYSTEM ALARMS WERE FOUND TO HAVE OCCURRED DURING TREATMENT. THE DEVICE IS FUNCTIONING POST TREATMENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPIRED DURING DIALYSIS TREATMENT. PRIOR TO TREATMENT, THE PATIENT¿S PRESSURES WERE NOT GREAT AND WAS SAID TO BE IN CRITICAL CARE. DEATH IS BELIEVED TO BE RELATED TO THE PATIENT'S PRE-EXISTING CONDITIONS AND NOT DUE TO THE TABLO DEVICE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499288 Tablo(R) Hemodialysis System DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. TABLO X HEMODIALYSIS SYSTEM 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Death