BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 11156954 · Received January 12, 2021

    Report

    Report Number
    3010355846-2021-00045
    Event Type
    Death
    Date Received
    January 12, 2021
    Date of Event
    December 13, 2020
    Report Date
    January 12, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2020, AND VERIFIED THAT THERE WAS NO ISSUE WITH THE SYSTEM WHICH CAUSED THE PATIENT EVENT. 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 20 MINUTES INTO A 12-HOUR SUSTAINED LOW-EFFICIENCY DIALYSIS (SLED) TREATMENT, THE MEDICAL PERSONNEL ENDED TREATMENT DUE THE PATIENT BEING HYPERTENSIVE AND UNABLE TO TOLERATE DIALYSIS. AS A RESULT, THE TREATMENT WAS STOPPED AND THE PATIENTS BLOOD WAS RETURNED SUCCESSFULLY. IT WAS REPORTED THAT APPROXIMATELY ONE-HOUR POST TREATMENT, THE PATIENT EXPIRED. THE PATIENT WAS NOT CONNECTED TO THE TABLO DEVICE WHEN THIS EVENT OCCURRED. 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. NOTE 1: THE PATIENT WAS HYPERTENSIVE PRIOR TO INITIATING THE DIALYSIS TREATMENT. NOTE 2: ANOTHER EVENT WAS REPORTED ON THIS SAME PATIENT THAT OCCURRED ON A DIFFERENT DAY (REFER TO MDR # 3010355846-2021-00042).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53609 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-000300 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death