BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA

    MDR report key: 6099557 · Received November 14, 2016

    Report

    Report Number
    6099557
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 31, 2016
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PRISMA CARTRIDGE WAS DEFECTIVE, THE CARTRIDGE WAS RETURNED TO BOX AND LABELED DEFECTIVE. IT NEVER REACHED THE PATIENT. THE PRISMA CARTRIDGE WAS RETURNED TO THE VENDOR ON 8/18/2016 FOR EVALUATION OF THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750910 PRISMA DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO RENAL PRODUCTS, INC. M100 16C0203G

    Patients

    Seq Age Sex Outcome Treatment
    1