BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM

    MDR report key: 19950655 · Received August 9, 2024

    Report

    Report Number
    3010355846-2024-00103
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A3A WAS AVAILABLE AT THE TIME OF THE PREVIOUS SUBMISSION, BUT INADVERTENTLY LEFT OFF THE FORM. INFORMATION FOR A4, A5, AND A6 IS NOT AVAILABLE AS IT WAS NOT PROVIDED BY THE REPORTER.

    Additional Manufacturer Narrative · 0

    REPORTED INCIDENT OF SUSPECTED ARTERIOVENOUS GRAFT (AVG) INFECTION WITH BLOOD CULTURE POSITIVE FOR PSEUDOMONAS ORYZIHABITANS. IT IS UNCLEAR IF THE ACCESS OR THE DEVICE WAS THE SOURCE. CLINICIAN AND PATIENT REPORT CONCERN THAT DEVICE MAY BE THE SOURCE; HOWEVER, NO CULTURES TAKEN FROM THE DEVICE IN QUESTION. INVESTIGATION WAS PERFORMED VIA LOG FILE REVIEW. THE INVESTIGATION CONFIRMED SHOWS ALL DISINFECTIONS COMPLETED APPROPRIATELY WITH NO CONSOLE RELATED ISSUES. NO EVIDENCE OF DEVICE MALFUNCTION. UNCLEAR CAUSE FOR INFECTION. INSTRUCTIONS FOR USE (IFU) WARNING: REGULAR CULTURES OF THE DIALYSATE SHOULD BE TAKEN TO ENSURE THAT THE BACTERIA AND ENDOTOXIN LEVELS IN THE DIALYSATE ARE ACCEPTABLE. ALSO, CHEMICAL DISINFECTION (FULL CHEM) MUST BE PERFORMED ON A WEEKLY BASIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD BLOODSTREAM INFECTION CAUSING THE PATIENT TO BE HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493289 TABLO HEMODIALYSIS SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H