BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1021532 · Received March 26, 2008

    Report

    Report Number
    3003464075-2008-00134
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NXSTAGE REQUESTED RETURN OF THE DISPOSABLE CARTRIDGE; HOWEVER, IT WAS LEARNED THROUGH FOLLOW UP THAT THE CARTRIDGE HAD BEEN DISCARDED. THE EXACT CAUSE OF THE BROKEN ARTERIAL LUER TIP CANNOT BE DETERMINED, HOWEVER IT WAS MOST LIKELY DUE TO EXCESSIVE FORCE USED WHILE CONNECTING TO THE PATIENT'S ACCESS. NXSTAGE WILL CONTINUE TO MONITOR AS PART OF THE ROUTINE COMPLAINT PROCESS. FACILITY STAFF HAS BEEN NOTIFIED. NEXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT, WHILE CONNECTING FOR RINSEBACK THE LUER TIP OF THE ARTERIAL LINE BROKE OFF INTO THE PATIENT'S FISTULA. RINSEBACK WAS COMPLETED WITH THE EXCEPTION OF TUBING SEGMENT FROM THE SALINE LINE TO THE ACCESS, RESULTING IN AN ESTIMATED BLOOD LOSS OF 30CC. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 7127710

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other