BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2221590 · Received August 18, 2011

    Report

    Report Number
    3003464075-2011-00091
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO AIR IN THE CARTRIDGE. ATTEMPTS TO REMOVE AIR WITH A 10CC SYRINGE WERE NOT SUCCESSFUL. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS AND FURTHER STATES TO USE A 20CC SYRINGE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    A VENOUS AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. ATTEMPTS TO REMOVE AIR WITH A 10CC SYRINGE WERE NOT SUCCESSFUL. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 210 CC. THE PT WAS HOSPITALIZED ON (B)(6) 2011 FOR ANEMIA, RECEIVED A BLOOD TRANSFUSION OF 1 UNIT OF PRBCS ON (B)(6) 2011 AND DISCHARGED TO HOME. NO OTHER 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-B 1047721

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention