BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3677276 · Received February 24, 2014

    Report

    Report Number
    3003464075-2014-00001
    Event Type
    Injury
    Date Received
    February 24, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 24, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE PATIENT'S DIAGNOSIS OF DIC CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED FOR EVALUATION OR LOT NUMBER PROVIDED. PATIENT INFO INCLUDING MEDICAL HISTORY WAS REQUESTED HOWEVER NOT PROVIDED. A REVIEW OF THE COMPLAINT DATABASE CONFIRMED THERE HAVE BEEN NO OTHER REPORTS OF DIC ASSOCIATED WITH CRRT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD & DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    AN UNSPECIFIED PATIENT ON CRRT WITH NO ANTICOAGULANT FOR 15 DAYS DEVELOPED DIC. THERAPY WAS DISCONTINUED ON AN UNSPECIFIED DATE AND REPLACED WITH HEMODIALYSIS AND DIC RESOLVED. THE PATIENT REC'D "MASSIVE" AMOUNTS OF CRYOPRECIPITATE AND PLATELETS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112963 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention