BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS DIALYZERS - OGDEN

    MDR report key: 3862780 · Received May 28, 2014

    Report

    Report Number
    1225714-2014-03583
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    May 7, 2010
    Report Date
    May 7, 2010
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION. RELATED MDR: 1225714-2014-03584.

    Description of Event or Problem · 1

    DURING A EIGHT WEEK, OPEN LABEL, SEQUENTIAL PHASE STUDY IN WHICH INDIVIDUAL SUBJECTS PROGRESSED THROUGH FOUR STUDY PERIODS EACH COMPROMISING SIX HD TREATMENTS OVER A TWO WEEK PERIOD. THE PATIENTS WERE GIVEN THEIR STANDARD BOLUS HEPARIN, THEN 100% OF THE STANDARD BOLUS DOSE, THEN 80% OF BOLUS STANDARD, THEN 66.7% OF BOLUS STANDARD. A PATIENT HAD A CLOT IN THE DIALYZER AND BLOODLINES AND REQUIRED A DIALYZER AND BLOODLINE CHANGE. BLOOD LOSS WAS NOT REPORTED. BLOOD LOSS FOR DIALYZER AND BLOODLINES APPROXIMATED AT LESS THAN 100ML. THIS WAS AN ANTICIPATED EVENT. SHE WAS WITHDRAWN FROM THE STUDY PER PROTOCOL. THE OUTCOME WAS RESOLVED ON (B)(6) 2010. THE SEVERITY OF THE EVENT WAS MILD AND THE RELATIONSHIP TO THE STUDY WAS ASSESSED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314945 FRESENIUS DIALYZERS - OGDEN FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SALINE| FMC ACIDS| HEMODIALYSIS MACHINE| BLOOD LINES| BICARBONATE| CITRASATE