BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1001090 · Received February 22, 2008

    Report

    Report Number
    3003464075-2008-00076
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 26, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. THE USER'S GUIDE ALSO PROVIDES ADEQUATE INSTRUCTIONS FOR REMOVING AIR FROM THE SYS. OCCASIONAL ALARMS DURING HEMODIALYSIS TREATMENTS ARE EXPECTED AND SHOULD NOT RESULT IN BLOOD LOSS IF DEVICE LABELING INSTRUCTIONS ARE FOLLOWED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO 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. A VENOUS PRESSURE LOW ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. AIR WAS INTRODUCED INTO THE SYS WHILE ATTEMPTING TO TROUBLESHOOT. RINSEBACK WAS NOT PERFORMED RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. NO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other