BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11363003 · Received February 22, 2021

    Report

    Report Number
    3010355846-2021-00055
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    January 23, 2021
    Report Date
    February 22, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 A "CODE BLUE" WAS CALLED ON A PATIENT APPROXIMATELY THREE MINUTES INTO A THREE HOUR DIALYSIS TREATMENT. THE TREATMENT WAS ENDED, BLOOD RETURNED AND FINAL BLOOD PRESSURE WAS NOT OBTAINED ON THE DEVICE DUE TO THE CODE SITUATION. IT WAS REPORTED THAT THE PATIENT REGAINED CONSCIOUSNESS AFTER THE BLOOD WAS RETURNED. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, THE MEDICAL DIRECTOR CLEARED AS NOT DIALYSIS RELATED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258926 TABLO X 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 77 YR Life Threatening