BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO X HEMODIALYSIS SYSTEM

    MDR report key: 11608258 · Received April 2, 2021

    Report

    Report Number
    3010355846-2021-00062
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 1, 2021
    Report Date
    April 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
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 A PATIENT CODED (CARDIAC ARREST) DURING A DIALYSIS TREATMENT. THE CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR) AND THE PATIENT WAS REVIVED. PRIOR TO DIALYSIS TREATMENT, THE PATIENT WAS IN CRITICAL CONDITION. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THIS EVENT WAS RELATED TO A TABLO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506733 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