BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 23864695 · Received December 22, 2025

    Report

    Report Number
    3010355846-2025-00020
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 21, 2025
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011204
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, NO DEFINITIVE CONCLUSION OR ROOT CAUSE HAS BEEN IDENTIFIED. ROOT CAUSE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ALARM FOR AIR IN LINES TWO TIMES DURING TREATMENT. BLOOD WAS DISCARDED TWICE DURING TREATMENT, RESULTING IN LOSS OF TWO CARTRIDGES OF BLOOD. PATIENT COMPLETED TREATMENT SUCCESSFULLY ON ANOTHER TABLO. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647500 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 Other