BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2423272 · Received January 17, 2012

    Report

    Report Number
    3003464075-2012-00004
    Event Type
    Injury
    Date Received
    January 17, 2012
    Date of Event
    December 19, 2011
    Report Date
    December 19, 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

    THE BLOOD LOSS EVENT IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING A RINSE BACK DUE TO VENOUS NEEDLE INFILTRATION. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN INITIATION OF A ROUTINE HEMODIALYSIS TREATMENT THE PATIENT'S VENOUS NEEDLE INFILTRATED. THE TREATMENT WAS DISCONTINUED AND THE BLOOD WAS NOT RINSED BACK. PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 141CC. FOLLOW-UP HB ON (B)(6) 2012 WAS 9.9; PREVIOUS HB WAS 10.6. IV IRON 300MG X 3 DOSES WAS ORDERED DUE TO LOW IRON STORES. NO OTHER MEDICAL INTERVENTION WAS REPORTED.

    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 1087721

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other