BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 9814263 · Received March 10, 2020

    Report

    Report Number
    3010355846-2020-00014
    Event Type
    Death
    Date Received
    March 10, 2020
    Date of Event
    February 8, 2020
    Report Date
    March 10, 2020
    Manufacturer
    OUTSET MEDICAL, INC
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K160866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTSET MEDICAL, INC. SYSTEMS ENGINEER HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. NO RELATED SYSTEM ALARMS WERE FOUND TO HAVE OCCURRED DURING TREATMENT. THE DEVICE IS FUNCTIONING POST TREATMENT. A REVIEW OF PRODUCTION RECORDS FOR THIS UNIT DID NOT NOTE ANY MANUFACTURING NONCONFORMANCES THAT WOULD CONTRIBUTE TO A PRODUCT EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING LOW BLOOD PRESSURE DURING SUSTAINED LOW EFFICIENCY DIALYSIS (SLED) TREATMENT. THE DISPLAY SETTING TOUCHSCREEN WENT BLANK DURING TREATMENT AFTER CHANGING THE ACID JUGS AND THE NURSE DECIDED TO END TREATMENT THREE HOURS INTO A TWELVE HOUR TREATMENT. THE NURSE WAS ABLE TO INITIATE "STOP TREATMENT" AND RETURN BLOOD TO THE PATIENT WITH NO ISSUES AND NO BLOOD LOSS. IT WAS NOTED THAT THE PATIENT HAD BEEN EXPERIENCING LOW BLOOD PRESSURE ISSUES PRE-TREATMENT IN ADDITION TO DURING TREATMENT. THE TABLO PROGRAM SPECIALIST (TPS) WAS NOTIFIED TWO DAYS LATER ((B)(6) 2020) THAT THE PATIENT PASSED AWAY THE EVENING OF (B)(6) 2020, AFTER TREATMENT; HOWEVER, DEATH WAS NOTED TO BE DUE TO THE PATIENT¿S PRE-EXISTING CONDITIONS AND NOT RELATED TO THE DIALYSIS TREATMENT OR TABLO UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276228 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC TABLO X HEMODIALYSIS SYSTEM 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 Death