BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE

    MDR report key: 17515604 · Received August 11, 2023

    Report

    Report Number
    3010355846-2023-00084
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    August 16, 2022
    Report Date
    August 11, 2023
    Manufacturer
    OUTSET MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    10850001011218
    PMA / PMN Number
    K190793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3/H6: THE CARTRIDGE HAS BEEN RETURNED FOR PRODUCT EVALUATION; HOWEVER, NO CONCLUSIONS / ROOT CAUSES WERE IDENTIFIED. A SUPPLEMENTAL MDR WILL BE FILED IF MORE INFORMATION IS RECEIVED. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER RETROSPECTIVE REVIEW AND REASSESSED AS REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS ARTERIAL POD SEPARATION ONE HOUR AND 30 MINUTES INTO PATIENT TREATMENT ON TABLO AND NO ALARM OCCURRED BEFORE AND DURING THE INCIDENT. THERE WAS AN ESTIMATE OF 400 - 500 ML BLOOD LOSS. IT WAS NOTED THAT THE PATIENT IS FEELING SICK AND MAY NEED TRANSFUSION. NOTE: USER STATES THE PATIENT MAY NEED BLOOD TRANSFUSION; HOWEVER, THIS CANNOT BE CONFIRMED, OTHER THAN THAT PATIENT WAS NOTED AS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762324 TABLO HEMODIALYSIS SYSTEM, TABLO CARTRIDGE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI OUTSET MEDICAL, INC. PN-0005644 D2213114 10850001011218

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other