BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 10420846 · Received August 18, 2020

    Report

    Report Number
    3010355846-2020-00023
    Event Type
    Death
    Date Received
    August 18, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 18, 2020
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K160866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. FIELD SERVICE ENGINEER (FSE) 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 THE PATIENT EXPIRED DURING DIALYSIS TREATMENT. CLINICAL STAFF INDICATED THAT PATIENT WAS ON A HIGH OBSERVATION UNIT AND THE PATIENT'S ATTENDING MEDICAL DOCTOR (MD) WAS EXPECTING A REGRESSION DUE TO THE ACUITY OF PATIENT'S PRE-EXISTING CONDITION. PATIENT WAS ON "MULTIPLE PRESSERS" AND BEGAN DECOMPENSATION DURING DIALYSIS. THE SITE DOES NOT BELIEVE THAT THIS WAS A DEVICE ISSUE OR MALFUNCTION, NOR THAT THE DIALYSIS TREATMENT ITSELF CAUSED THE DECOMPENSATION BUT RATHER COINCIDENTAL TIMING DUE TO PATIENT CONDITION. THE TREATING TEAM ATTRIBUTED THE EVENT TO THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885009 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 47 YR Death