BEUDAMED
    FDA Adverse Event Death Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11497594 · Received March 16, 2021

    Report

    Report Number
    3010355846-2021-00060
    Event Type
    Death
    Date Received
    March 16, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 16, 2021
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    00850001011112
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 A PATIENT CODED WHEN THERE WAS APPROXIMATELY 10 SECONDS LEFT ON BLOOD RETURN AT THE END OF TREATMENT AND EXPIRED. IT WAS REPORTED THAT THE PATIENT WAS IN INTENSIVE CARE UNIT (ICU) AND HAD BEEN DIALYZED EARLIER IN THE WEEK WITH STABLE CONDITIONS. THE PATIENT WAS NOT RESUSCITATED AS SHE HAD A "DO NOT RESUSCITATE" (DNR) ORDER IN PLACE. 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 CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396040 TABLO X HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0006000 00850001011112

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death