BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET

    MDR report key: 3112275 · Received June 28, 2006

    Report

    Report Number
    3112275
    Event Type
    Malfunction
    Date Received
    June 28, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 14, 2006
    Manufacturer
    FRESENIUS OF NORTH AMERICA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING MACHINE SET-UP, IT WAS NOTED THAT THE HEPARIN LINE CONSISTED OF SOLID TUBING MATERIAL SO THAT THERE WAS NO OPENING IN THE HEPARIN TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET DIALYSIS MACHINE TUBING FPA FRESENIUS OF NORTH AMERICA COMBISET 03-2722-9 SER019

    Patients

    Seq Age Sex Outcome Treatment
    1