BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO BLOOD TUBING SET W/TP

    MDR report key: 18527881 · Received January 17, 2024

    Report

    Report Number
    1056186-2024-00001
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 17, 2024
    Manufacturer
    NIPRO (THAILAND) CORP. LTD.
    Product Code
    FJK
    UDI-DI
    00383790008808
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING DIALYSIS TREATMENT, MACHINE ALARMED INSTANTLY FOR BLOOD LEAK WITHIN THE DIALYZER, VISIBLE IN THE ARTERIAL COUPLER TUBING. PATIENT WAS REMOVED FROM THE MACHINE WITHOUT RETURNING THE PATIENT'S BLOOD (APPROXIMATELY 250ML OF BLOOD LOSS) . PER CHARGE NURSE, PATIENT REQUIRED NO FOLLOW UP OR TRANSFUSION POST INCIDENT. DIALYZER USED: F250 DIALYZER. MACHINE: SURDIAL DX HEMODIALYSIS SYSTEM. PRODUCTG CODE: MC+SDX01. 510K: K182940.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421724 NIPRO BLOOD TUBING SET W/TP BLOODLINE FJK NIPRO (THAILAND) CORP. LTD. BL+A430/V912 22C18 00383790008808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention