BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLO HEMODIALYSIS SYSTEM PRO+

    MDR report key: 19258309 · Received May 7, 2024

    Report

    Report Number
    19258309
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 19, 2024
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TABLO BLOOD FLOW/PUMP ISSUE OCCURRED DURING DIALYSIS TREATMENT. BLOOD PUMP ERRORS AT THE BEGINNING OF TREATMENTS WHEN STARTING AT [TIME REDACTED] AND HAVE TO GRADUALLY INCREASE AFTER A FEW MINUTES AND THEN AFTER A FEW MORE MINUTES LATER. TREATMENT IS ABLE TO BE COMPLETED OTHERWISE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670588 TABLO HEMODIALYSIS SYSTEM PRO+ DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0007001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown