BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 11121633 · Received January 5, 2021

    Report

    Report Number
    3010355846-2021-00043
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 5, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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, OTHER, MORE SERIOUS, COMPLICATIONS ARISING FROM DIALYSIS, SUCH AS HEMORRHAGE, AIR EMBOLISM, ACIDOSIS, ALKALOSIS OR HEMOLYSIS, CAN CAUSE SERIOUS PATIENT INJURY OR DEATH. OUTSET MEDICAL, INC. FIELD SERVICE ENGINEER (FSE) REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020, IT IS BELIEVED THAT THE UNIT FUNCTIONED AS INTENDED BY TRIGGERING SEVERAL ALARMS FOR LOW SYSTOLIC BLOOD PRESSURE. THE LOG REVIEW ALSO CONFIRMED THAT THE ALARMS WERE CLEARED BY THE USER. THE CONSOLE IS OPERATING AS INTENDED AFTER THE EVENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WENT INTO RESPIRATORY FAILURE APPROXIMATELY ONE HOUR INTO DIALYSIS TREATMENT ON A TABLO DEVICE. IT WAS REPORTED THAT THE PATIENT'S VITAL SIGNS WERE UNSTABLE PRIOR TO AND DURING TREATMENT; THEREFORE TREATMENT WAS ENDED. NO FURTHER INFORMATION WAS PROVIDED. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THE TABLO DEVICE WAS THE CAUSE OF THIS EVENT; RATHER, THIS WAS ATTRIBUTED THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17835 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 Life Threatening