BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE

    MDR report key: 6119346 · Received November 21, 2016

    Report

    Report Number
    8030638-2016-00016
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 21, 2016
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS UNDERGOING A DIALYSIS TREATMENT WHICH INCLUDED A CARTRIDGE BLOOD LINE. DURING TREATMENT AN EXTERNAL LEAK FROM THE CHAMBER WAS IDENTIFIED. TREATMENT WAS TEMPORARILY STOPPED AND RESTARTED WITH A NEW BLOOD LINE. THE DATE OF THE EVENT IS UNKNOWN THEREFORE THE DATE IN SECTION B3 DATE OF EVENT IS AN ESTIMATED DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767522 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other