BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1851157 · Received September 29, 2010

    Report

    Report Number
    3003464075-2010-00091
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    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 BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER, AS DIRECTED IN THE USER'S GUIDE WHEN AN ALARM CANNOT BE RESOLVED. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSE OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THE ACTUAL CAUSE OF THE ALARM IS UNKNOWN. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    MULTIPLE ARTERIAL AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. TREATMENT WAS DISCONTINUED WITH A PARTIAL RINSEBACK PERFORMED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 140CC. THE PATIENT'S STANDARD EPOGEN DOSE WAS RESTARTED. 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 0037704

    Patients

    Seq Age Sex Outcome Treatment
    1 Other