BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 23785560 · Received December 11, 2025

    Report

    Report Number
    3010355846-2025-00017
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 15, 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
    PA, 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. TABLO INSTRUCTIONS FOR USE (IFU) WARNING AND CAUTION: WHEN THE BLOOD IN DIALYSATE ALARM OCCURS, THE DIALYSATE MUST BE TESTED FOR THE PRESENCE OF BLOOD, AND THE SYSTEM ALARM SCREEN PROMPT MUST BE ANSWERED TO CLEAR THE ALARM. FOLLOW THE ALARM SCREEN INSTRUCTIONS TO SAMPLE THE EFFLUENT DIALYSATE AND TEST THE SAMPLE AS INSTRUCTED BY YOUR CENTER. THE SYSTEM WILL PREVENT TREATMENT CONTINUATION IN THE EVENT OF THE PRESENCE OF BLOOD IN THE DIALYSATE. ALWAYS IMMEDIATELY CONTACT YOUR CENTER IN THE EVENT OF A BLOOD LOSS EVENT. OUTSET TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOG WITH THE PROCEDURE DATE OF 15-NOV-2025 AND CONFIRMED THAT THE CONSOLE IS FUNCTIONING AS DESIGNED WHEN A BLOOD LEAK IS DETECTED. THE ISSUE IS RELATED TO THE DIALYZER, NOT THE CONSOLE. 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 POSITIVE BLOOD LEAK ALERT TWICE DURING A TREATMENT RUN AND THE NURSE CONFIRMED POSITIVE BLOOD LEAK WITH THE TESTING STRIPS TWICE. BLOOD WAS DISCARDED TWICE DURING TREATMENT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 600 ML. PATIENT COMPLETED TREATMENT SUCCESSFULLY ON ANOTHER TABLO. NO PATIENT ADVERSE EVENTS WERE NOTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625827 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