BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1023318 · Received April 1, 2008

    Report

    Report Number
    3003464075-2008-00144
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PATIENT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. 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 ALARM CANNOT BE DETERMINED. NO SIMILAR PROBLEMS HAVE BEEN REPORTED SUBSEQUENT TO THIS EVENT. THE USER'S GUIDE IDENTIFIES PROBABLE CAUSES OF THE ALARM AND PROVIDES ADEQUATE INSTRUCTIONS TO RESOLVE THE ALARM. 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 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. ARTERIAL AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. ATTEMPTS MADE TO REMOVE AIR WERE UNSUCCESSFUL. 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 82 YR Other