BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10819533 · Received November 10, 2020

    Report

    Report Number
    3010355846-2020-00030
    Event Type
    Death
    Date Received
    November 10, 2020
    Date of Event
    October 17, 2020
    Report Date
    November 10, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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 A COVID POSITIVE PATIENT ON A VENTILATOR WITH MULTIPLE COMORBIDITIES HAD INCREASED VENOUS PRESSURE DUE TO CLOTTING IN THE VENOUS DRIP CHAMBER DURING A DIALYSIS TREATMENT. THE NURSE STOPPED TREATMENT AND THE PATIENT¿S BLOOD WAS RETURNED SUCCESSFULLY. WHILE THE NURSE WAS SETTING UP THE TABLO DEVICE TO CONTINUE TREATMENT, THE PATIENT WENT INTO CARDIAC ARREST AND SUBSEQUENTLY EXPIRED, HOWEVER, THE PATIENT WAS NOT CONNECTED TO THE TABLO DEVICE DURING THE EVENT. IT WAS REPORTED THAT THE PATIENT ENDED UP WITH CHEST TUBES FOR PNEUMOTHORAX, MASSIVE BLOOD TRANSFUSION PROTOCOL AND FFP ADMINISTRATION AND DESPITE 1.5 HOURS OF RESUSCITATION, THE PATIENT EXPIRED ON (B)(6) 2020. IT IS NOT BELIEVED THAT THE TABLO DEVICE CAUSED THE EVENT; RATHER, THE TREATING STAFF ATTRIBUTED THE EVENT TO PATIENT¿S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281587 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0003000 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O