BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 23785219 · Received December 11, 2025

    Report

    Report Number
    3010355846-2025-00016
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 11, 2025
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011204
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. OUTSET TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOG AND CONFIRMED THAT THE SYSTEM OPERATED WITHIN EXPECTED PERFORMANCE SPECIFICATIONS. DEVICE REMOVED THE FLUID AMOUNT THAT WAS ENTERED. OUTSET IS UNABLE TO VALIDATE THE REPORT THAT THE DEVICE REMOVED MORE OR LESS THAN WHAT WAS ENTERED. 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

    THE CUSTOMER SITE REPORTED CONCERNS REGARDING INACCURATE FLUID REMOVAL ON A TABLO SYSTEM DURING PATIENT TREATMENT. PATIENTS' BLOOD PRESSURE WAS AS LOW AS 75/39 WITH SYMPTOMS OF DIZZINESS AND NAUSEA AT THE END OF TREATMENT. PATIENT WAS PROVIDED FLUID INTERVENTIONS AND WAS DISCHARGED FROM DIALYSIS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186217 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 Male Other