BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 20419004 · Received October 10, 2024

    Report

    Report Number
    3010355846-2024-00104
    Event Type
    Death
    Date Received
    October 10, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 10, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011204
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION OR NONCONFORMANCE, 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. FROM THE INFORMATION PROVIDED, EVENT CAUSALITY COULD NOT BE DETERMINED. MULTIPLE FOLLOW UP ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE INITIAL REPORTER WERE UNSUCCESSFUL; THEREFORE, ROOT CAUSE OF THE EVENT WAS NOT ABLE TO BE CONFIRMED. HOWEVER IS IT NOT SUSPECTED TO BE PRODUCT RELATED. OUTSET MEDICAL, INC. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SITE SYSTEM LOG WITH A PROCEDURE DATE OF (B)(6) 2024 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. A REVIEW OF PRODUCTION RECORDS FOR THIS SERIAL NUMBER DID NOT NOTE ANY RELATED MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CODE BLUE, BLOOD WAS NOT RETURNED AND PATIENT EXPIRED DURING TREATMENT. THE TREATMENT STARTED AT 8:00PM AND PATIENT CODED AT 11:00PM, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029128 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. 00850001011204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death