BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO DIALYSIS MACHINES

    MDR report key: 20037859 · Received August 21, 2024

    Report

    Report Number
    MW5158707
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Report Date
    August 19, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOSPITAL UTILIZATION OF TABLO DIALYSIS MACHINES AND BLOOD LINES FROM LOT NUMBERS WITH KNOWN PROBLEMS. USE OF THESE PRODUCTS AND EQUIPMENT IS EXPOSING CRITICALLY-ILL PATIENTS TO UNNECESSARILY HAZARDOUS CONDITIONS INVOLVING RISK OF SIGNIFICANT BLOOD LOSS, HEMOLYSIS, AIR EMBOLISM, AND SYSTEMIC INFECTION. FAULTY BLOOD LOT LINES ARE CAUSING BLOOD LEAKS INTERNALLY AND EXTERNALLY. INTERNAL BLOOD LEAKS ARE NEARLY UNDETECTABLE, LEADING TO AN UNKNOWN LEVEL OF CONTAMINATION. SINCE MACHINES ARE NOT PATIENT-SPECIFIC, INDIVIDUAL PATIENT EXPOSURE TO POTENTIAL BLOOD BORNE PATHOGENS, SUCH AS HEPATITIS B, IS INCREASED. HOSPITAL USE OF EXPIRED ACID BATHS FOR DIALYSIS TREATMENTS AND SHARING OF SINGLE-USE DIALYSATE BATHS BETWEEN MULTIPLE PATIENTS WHEN STOCK IS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363739 TABLO DIALYSIS MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. M24192L03S01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown