BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11402205 · Received March 2, 2021

    Report

    Report Number
    3010355846-2021-00058
    Event Type
    Death
    Date Received
    March 2, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 2, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 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 THE PATIENT EXPIRED A FEW MINUTES INTO A DIALYSIS TREATMENT. THE CARE PERSONNEL REPORTED THAT THE PATIENT WAS VERY ILL PRIOR TO THE TREATMENT AND AN ATTEMPT WAS MADE TO RESUSCITATE THE PATIENT, BUT THAT WAS UNSUCCESSFUL. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THE TABLO DEVICE WAS THE CAUSE OF THIS EVENT; RATHER, THIS WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295209 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