BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11669732 · Received April 15, 2021

    Report

    Report Number
    3010355846-2021-00066
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 14, 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 EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 MINUTES INTO DIALYSIS TREATMENT, THE PATIENT CODED. DIALYSIS TREATMENT WAS STOPPED AS CARE TEAM INITIATED CHEST COMPRESSIONS, ADMINISTERED EPINEPHRINE AND THE PATIENT REVIVED. PATIENT WAS STABLE AFTER BEING REVIVED. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572101 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 Life Threatening| R