BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M100 SET

    MDR report key: 6049291 · Received October 21, 2016

    Report

    Report Number
    8010182-2016-00081
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 21, 2016
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Removal / Correction Number
    Z-2202-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN

    Description of Event or Problem · 1

    DURING THERAPY WITH A PRISMAFLEX SET (UNKNOWN TYPE), IT WAS REPORTED THAT THE CONNECTION TUBE OF THE EFFLUENT BAG WAS STICKING AND THE MALE LUER LOCK ON THE EFFLUENT LINE WAS FOUND BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698258 PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO INDUSTRIES 106697 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PRSIMAFLEX (SN:UNKNOWN)