BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10364762 · Received August 4, 2020

    Report

    Report Number
    3010355846-2020-00022
    Event Type
    Death
    Date Received
    August 4, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 4, 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

    FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. 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 THE PATIENT EXPIRED ABOUT 44 MINUTES INTO DIALYSIS TREATMENT. CLINICAL STAFF INDICATED THAT PATIENT WAS AN EXISTING DIALYSIS PATIENT WHO BECAME INFECTED WITH THE NOVEL CORONAVIRUS (COVID-19). PATIENT WAS ON BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) MACHINE AND HAD A DO-NOT-RESUSCITATE (DNR) ORDER PRIOR TO BEING PLACED ON THE TABLO CONSOLE AS THE PATIENT WAS UNSTABLE. THE TREATING TEAM ATTRIBUTED THE EVENT TO THE PATIENT'S PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825234 TABLO 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 50 YR Death