BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 24228069 · Received January 30, 2026

    Report

    Report Number
    3010355846-2026-00009
    Event Type
    Death
    Date Received
    January 30, 2026
    Date of Event
    January 3, 2026
    Report Date
    January 30, 2026
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011204
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 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 MEDICAL, INC. TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOG WITH THE PROCEDURE DATE OF (B)(6) 2026 AND FOUND NO ISSUE WITH THE CONSOLE AND CONSOLE OPERATED AS INTENDED. 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 A 70-YEAR-OLD MALE PATIENT WAS UNRESPONSIVE AND GASPING DURING TREATMENT DUE TO NEEDLE DISLODGEMENT. TREATMENT WAS ENDED AND AN ESTIMATE OF 150ML BLOOD WAS LOSS. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED; HOWEVER, THE PATIENT EXPIRED. THERE WAS NO ALLEGED MALFUNCTION OF TABLO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287139 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. 00850001011204

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death