BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10570987 · Received September 22, 2020

    Report

    Report Number
    3010355846-2020-00027
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 22, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE 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. OUTSET MEDICAL, INC. PRODUCT 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 DURING DIALYSIS TREATMENT, THE PATIENT HAD A CEREBROVASCULAR ACCIDENT (CVA) AFTER 40 MINUTES OF INTERMITTENT HEMODIALYSIS (IHD) TREATMENT ON TABLO, AFTER A PERIOD OF TIME THE PATIENT WAS UNRESPONSIVE AND THE NURSE RETURNED THE PATIENT¿S BLOOD WITHOUT ISSUE WITH THE TABLO SYSTEM. IT WAS REPORTED THAT THE PATIENT DID RETURN TO CONSCIOUSNESS; HOWEVER, HIS CONDITION AND RESPIRATORY STATUS WORSENED THROUGH THE NIGHT, AND IT WAS DECIDED NOT TO TAKE EXTRAORDINARY MEASURES. POST TREATMENT, THE PATIENT EXPIRED AT 2:00 AM ON (B)(6) 2020. THE TREATING TEAM ATTRIBUTED THE EVENT TO THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032919 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0003000 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R