BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2008K HEMODIALYSIS MACHINE

    MDR report key: 3862782 · Received May 28, 2014

    Report

    Report Number
    1225714-2014-03580
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 21, 2010
    Report Date
    April 21, 2010
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    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.

    Description of Event or Problem · 1

    DURING AN EIGHT WEEK, OPEN LABEL, (B)(6) 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 WAS FOUND TO HAVE A SIGNIFICANT DECLINE IN HEMOGLOBIN OF 6.6 G/DL ON (B)(6) 2010. HIS PRIOR VALUE ON (B)(6) 2010 WAS 10.2, AND HE HAD BEEN INCREASING AFTER RECENT INCREASE IN HIS EPO DOSE. EARLIER IN THE MONTH HIS IRON STORES WERE FOUND TO BE ADEQUATE WITH TSAT OF 30% ON (B)(6) 2010. THE PATIENT WAS WITHDRAWN FROM THE STUDY, REPEAT HEMOGLOBIN CONFIRMED THE LOW VALUE AND HE DECLINED HOSPITALIZATION FOR FURTHER EVALUATION. THE PATIENT WAS HEMODYNAMICALLY STABLE DURING DIALYSIS ON (B)(6) 2010 AND NO INJURY WAS REPORTED. THIS EVENT WAS CONSIDERED A SERIOUS ADVERSE EVENT AS HOSPITALIZATION WAS DEEMED NECESSARY. THE EVENT WAS ANTICIPATED PER STUDY PROTOCOL. THE OUTCOME WAS ONGOING. THE SEVERITY OF THE EVENT WAS SEVERE AND THE RELATIONSHIP TO THE STUDY WAS ASSESSED AS NOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314957 2008K HEMODIALYSIS MACHINE KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

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