BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS HANSON LINE

    MDR report key: 8416255 · Received March 13, 2019

    Report

    Report Number
    8416255
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 25, 2019
    Product Code
    FID
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MACHINE WAS LEAKING WATER FROM VENOUS HANSON LINE DURING HEMODIALYSIS. THERE NOTED TO BE A CRACK AT THE LINE OF CONNECTION. PATIENT HAD TO BE RETURNED AND PUT ON A DIFFERENT MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208883 VENOUS HANSON LINE FID

    Patients

    Seq Age Sex Outcome Treatment
    1