BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 23262558 · Received October 9, 2025

    Report

    Report Number
    3010355846-2025-00012
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 9, 2025
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. TABLO HEMODIALYSIS SYSTEM INSTRUCTIONS FOR USE (IFU) WARNING: MONITOR PATIENT¿S BLOOD PRESSURE AND GENERAL PHYSICAL STATUS DURING TREATMENT AND INITIATE APPROPRIATE REMEDIAL MEASURES OR THERAPY. PARTICULARLY MONITOR THE PATIENT FOR SYMPTOMS THAT INDICATE LOW BLOOD PRESSURE, INCLUDING HEADACHE, WEAKNESS, BLURRED VISION, DIZZINESS, CRAMPS, NAUSEA. OUTSET TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM LOG WITH THE PROCEDURE DATE OF (B)(6) 2025 AND CONFIRMED THAT THE CONSOLE FUNCTIONED AS INTENDED. THERE WERE NO CONSOLE RELATED ISSUES NOTED IN THE LOG FILE. ALTHOUGH A CARTRIDGE LEAK WAS REPORTED, IT WAS NOT ABLE TO BE DETERMINED IF THE CARTRIDGE MALFUNCTIONED. 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 PATIENT FELL ASLEEP DURING TREATMENT AND BLOOD LINE LEAKED FROM CARTRIDGE. TREATMENT CONTINUED FOR FOUR EXTRA HOURS WHILE PATIENT WAS UNRESPONSIVE AND/OR ASLEEP. IT WAS REPORTED THAT THE PATIENT DID NOT CHECK BLOOD PRESSURE BEFORE OR DURING TREATMENT, WHICH LED TO A POSSIBLE SYNCOPE EPISODE. AN ESTIMATE OF 500CC OF BLOOD WAS LOST AND PATIENT WAS HOSPITALIZED FOR ONE WEEK DUE TO BLOOD PRESSURE BEING 77/35 AND BACTEREMIA INFECTION. PATIENT HAS SINCE COMPLETED RESPITE CARE AND RETURNED TREATING AT HOME. ADDITIONALLY, IT WAS REPORTED THAT PATIENT¿S CAREGIVER WAS ABSENT DURING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304616 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| H