BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11593139 · Received March 30, 2021

    Report

    Report Number
    3010355846-2021-00061
    Event Type
    Death
    Date Received
    March 30, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 30, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. TECHNICAL TEAM HAS REVIEWED SITE SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2021 AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT DEATH. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 14 MINUTES INTO TREATMENT, A PATIENT CODED AND EXPIRED. IT WAS REPORTED THAT THE PATIENT WAS ON VENTILATOR, ALERT BUT NOT ORIENTED; THE CARE PERSONNEL BELIEVES THAT THE PATIENT SUFFERED A CARDIAC ARREST, AS THE PATIENT'S SATURATION WAS LOW AND HEART RATE VERY HIGH. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, THE PATIENT DEATH WAS UNRELATED TO THE TABLO DEVICE, RATHER THEY ATTRIBUTED IT TO THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489406 TABLO X 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 Death