BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX F250NRE DIALYZER

    MDR report key: 2970097 · Received February 15, 2013

    Report

    Report Number
    1713747-2013-00035
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K082414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS NURSE HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE BLOOD STRIPS TESTED POSITIVE FOR BLOOD LEAK; LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 200 ML'S PATIENT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66872 OPTIFLUX F250NRE DIALYZER HEMODIALYSIS DIALYZER FJI FRESENIUS MEDICAL CARE NORTH AMERICA 12PU02011

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR FRESENIUS 2008K MACHINE