BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10189009 · Received June 24, 2020

    Report

    Report Number
    3010355846-2020-00021
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 24, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K160866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE (IFU) WITH THE TABLO SYSTEM INCLUDES, BUT ARE NOT LIMITED TO, CLOTTING MAY BE EVIDENCED BY HIGH VENOUS PRESSURE, DARK BLOOD IN LINES OR DRIP CHAMBERS, VISIBLE CLOTS IN THE DRIP CHAMBER OR DIALYZER. FAILURE TO RESPOND TO CLOTTING MAY EXPOSE THE BLOOD CIRCUIT TO SUSTAINED HIGH PRESSURES LEADING TO A POSSIBLE BLOOD LEAK OR HEMOLYSIS (BLOOD CELL DAMAGE). OUTSET MEDICAL INC. FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED ISSUE. THE REPORTED ISSUE WAS NOT REPRODUCED DURING FIELD EVALUATION, AND UNIT WAS DEEMED OPERABLE. 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 PATIENT WITH VESSEL STENOSIS AND A PERMANENT CATHETER EXPERIENCED LOSS OF CONSCIOUSNESS THREE HOURS INTO TREATMENT, TREATMENT WAS ENDED. DURING TREATMENT THERE WAS INCREASE IN VENOUS PRESSURE THAT COULD NOT BE OVERCOME, AND NURSE WAS UNABLE TO MOVE PAST THE HIGH VENOUS PRESSURE; SUBSEQUENTLY, PATIENT LOSS APPROXIMATELY 200 CC OF BLOOD DUE TO POSSIBLE CLOTTING. THE NURSE ADMINISTERED APPROXIMATELY 500 CC FLUID BOLUS THROUGH THE ARTERIAL CATHETER PORT AS THE VENOUS CATHETER PORT WAS VERY DIFFICULT TO FLUSH OR ASPIRATE. IT WAS NOTED THAT THE NURSE DID NOT FLUSH THE SYSTEM AT ANY TIME BEFORE TO ATTEMPT TO VISUALIZE THE DIALYZER OR VENOUS DRIP CHAMBER (VDC). THE PATIENT RECOVERED AND IS STABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM OUTSET MEDICAL INC. CLINICAL MANAGER ON 6/18/2020, WHICH INDICATED THAT THE SITE DIALYSIS DIRECTOR PRESUMES THE PATIENT SIMPLY CLOTTED AND THE EVENT WAS NOT ATTRIBUTED TO A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652882 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 Other| R