BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2530736 · Received March 27, 2012

    Report

    Report Number
    3003464075-2012-00017
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 27, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED FILTER WAS EXAMINED AND A SMALL CRACK ON THE SIDE OF THE FILTER HOUSING HEADER CAP WAS IDENTIFIED. THE EXACT CAUSE OF THE CRACK WHICH RESULTED IN AN EXTERNAL BLOOD LEAK AFTER 14 HOURS OF TREATMENT CANNOT BE DETERMINED. THE USER GUIDE WARNS NOT TO TAP THE FILTER AGAINST A HARD SURFACE. THE CYCLER SERIAL NUMBER WAS NOT RECORDED SO A LOG FILE IS NOT AVAILABLE TO ANALYZE THE TREATMENT DATA. DEVICE LOT HISTORY INDICATED THAT ALL FILTERS PASSED THE DYNAMIC STRESS TEST, AS WELL AS 100% INTEGRITY TEST PRIOR TO RELEASE. NO OTHER SIMILAR DEFECTS HAVE BEEN IDENTIFIED FOR THIS LOT OF FILTERS. THIS APPEARS TO BE AN ISOLATED EVENT. NXTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN EXTERNAL FILTER BLOOD LEAK OCCURRED AFTER 14 HOURS OF EXTENDED CVVHD TREATMENT. THE REPORTER STATED THERE WERE NO ALARMS OR INDICATION OF INCREASED PRESSURES PRIOR TO THE LEAK. CLINICAL PERSONNEL INDICATED THAT IT WAS POSSIBLE THAT THE FILTER MAY HAVE BEEN DROPPED OR DAMAGED. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE APPROXIMATELY 200CC BLOOD LOSS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 1117801

    Patients

    Seq Age Sex Outcome Treatment
    1