BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1973827 · Received January 14, 2011

    Report

    Report Number
    3003464075-2011-00004
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED EVENT IS ATTRIBUTED TO THE OPERATOR NOT FOLLOWING INSTRUCTIONS PER THE USER'S GUIDE. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS, AS WELL AS ADEQUATE INSTRUCTIONS FOR MAKING PT CONNECTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    VENOUS AIR ALARMS OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR FAILED TO CLAMP THE SALINE LINE PRIOR TO STARTING TREATMENT WHICH INTRODUCED AIR INTO THE EXTRACORPOREAL BLOOD CIRCUIT. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S STANDARD EPOGEN DOSE WAS INCREASED. 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 0097704

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other