BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 24316113 · Received February 11, 2026

    Report

    Report Number
    3010355846-2026-00015
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 11, 2026
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011204
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    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 MEDICAL, INC. TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOG FOR THE PROCEDURE PERFORMED ON (B)(6) 2026 AND CONFIRMED THAT THE CONSOLE FUNCTIONED AS INTENDED. NO ISSUES OR ABNORMALITIES WERE IDENTIFIED IN THE SYSTEM PERFORMANCE. A REVIEW OF PRODUCTION RECORDS FOR THIS SERIAL NUMBER DID NOT NOTE ANY RELATED MANUFACTURING NONCONFORMANCE'S THAT WOULD CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 0

    AN (B)(6) MALE PATIENT WITH END-STAGE RENAL DISEASE ON PALLIATIVE CARE UNDERWENT HEMODIALYSIS. DURING TREATMENT, THE VENOUS NEEDLE BECAME DISLODGED, LEADING TO SIGNIFICANT BLOOD LOSS. THE PATIENT REMAINED ALERT AND ORIENTED BUT DEVELOPED HYPOTENSION SECONDARY TO EXSANGUINATION. MEDICAL STAFF INITIATED SALINE BOLUSES AND ADMINISTERED BLOOD TRANSFUSION. THE PATIENT WAS TRANSFERRED FROM THE MEDICAL-SURGICAL UNIT TO THE INTENSIVE CARE UNIT FOR FURTHER CARE. NO ALLEGED MALFUNCTION OF THE DEVICE WAS REPORTED. THE PATIENT EXPIRED THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373615 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. 00850001011204

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention| H