BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1242387 · Received November 21, 2008

    Report

    Report Number
    3003464075-2008-00603
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS DUE TO THE OPERATOR RUNNING OUT OF SALINE AND NOT COMPLETING RINSEBACK FOLLOWING AN UNRECOVERABLE ALARM. THE USER'S GUIDE STATES TO HAVE 300-500CC OF SALINE AVAILABLE FOR RINSEBACK. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OCCURRED. THE EXACT CAUSE OF THE REPORTED ALARMS IS NOT KNOWN. THE USER'S GUIDE INCLUDES PROBABLE CAUSES AND TROUBLESHOOTING STEPS FOR ALARM RECOVERY. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. OCCASIONAL ALARMS DURING DIALYSIS ARE EXPECTED AND SHOULD NOT RESULT IN BLOOD LOSS IF DEVICE LABELING IS FOLLOWED. A DIRECT CORRELATION BETWEEN THE NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF WERE 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, HIGH VENOUS PRESSURE ALARM OCCURRED THAT COULD NOT BE RESOLVED. TREATMENT WAS DISCONTINUED BUT ONLY A PARTIAL RINSEBACK OF THE PATIENT'S BLOOD WAS PERFORMED AS THE OPERATOR RAN OUT OF SALINE TO PERFORM THE RINSEBACK. AN ESTIMATED 165CC BLOOD LOSS OCCURRED. 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 8097702

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other