BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F180NR DIALYZER FILTER

    MDR report key: 1222244 · Received November 5, 2008

    Report

    Report Number
    MW5008900
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 5, 2008
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEMODIALYSIS TREATMENT INITIATED WITHOUT DIFFICULTY. WITHIN MINUTES, THE BLOOD LEAK DETECTOR ALARM WENT OFF. VISIBLE BLOOD WAS NOTED IN THE DIALYSATE LINES. TREATMENT WAS TERMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 F180NR DIALYZER FILTER DIALYZER FILTER KDI FRESENIUS MEDICAL CARE NORTH AMERICA F180NR BATCH # 8JU104

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR