BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

    MDR report key: 23873404 · Received December 22, 2025

    Report

    Report Number
    3010355846-2025-00021
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 22, 2025
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    10850001011256
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TABLO INSTRUCTIONS FOR USE (IFU) WARNING AND CAUTION: THE LOW VENOUS PRESSURE ALARM MAY NOT OCCUR WITH EVERY DISCONNECTION OR NEEDLE DISLODGEMENT. CHECK ALL BLOOD LINES FOR LEAKS AFTER THE TREATMENT HAS STARTED. KEEP ACCESS SITES UNCOVERED AND MONITORED. IMPROPER BLOOD LINE CONNECTIONS OR NEEDLE DISLODGEMENTS CAN RESULT IN EXCESSIVE BLOOD LOSS, SERIOUS INJURY, AND DEATH. SYSTEM ALARMS MAY NOT OCCUR IN EVERY BLOOD LOSS SITUATION. OUTSET TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOG WITH THE PROCEDURE DATE OF (B)(6) 2025 AND THE TABLO CONSOLE ISSUED A LOW VENOUS PRESSURE ALARM, WHICH WAS SUBSEQUENTLY CLEARED BY THE USER. NO ADDITIONAL CONDITIONS WERE PRESENT IN THE LOGFILE THAT WOULD HAVE TRIGGERED FURTHER ALARMS, AND NO EVIDENCE OF CONSOLE MALFUNCTION WAS IDENTIFIED BASED ON THE AVAILABLE SYSTEM DATA. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE DETERMINATION COULD NOT BE MADE AS TO WHETHER THE ALARM WAS DIRECTLY RELATED TO THE REPORTED BLOOD LEAK. ADDITIONALLY, THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE REPORTED ISSUE USING CARTRIDGE FROM THE SAME LOT NUMBER. A REVIEW OF PRODUCTION RECORDS FOR THIS LOT NUMBER DID NOT NOTE ANY RELATED MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED A 45-YEAR-OLD MALE PATIENT EXPERIENCED LOW BLOOD PRESSURE AND BECAME UNRESPONSIVE DURING TREATMENT. IT WAS REPORTED THAT BLOOD LEAKED FROM CARTRIDGE DURING TREATMENT; THE TOTAL VOLUME OF BLOOD LOSS IS UNKNOWN. CARE GIVER DIALED 911, EMERGENCY MEDICAL SERVICES (EMS) ARRIVED, STABILIZED THE PATIENT AND TRANSPORTED HIM TO THE HOSPITAL. AT THE HOSPITAL, THE PATIENT RECEIVED TWO UNITS OF BLOOD. THE PATIENT HAS SINCE STABILIZED AND HAS BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329903 TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. M25203L03S01-0835 10850001011256

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R