BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1982218 · Received January 24, 2011

    Report

    Report Number
    3003464075-2011-00012
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 26, 2010
    Report Date
    December 26, 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 BLOOD LOSS IS ATTRIBUTED TO POSSIBLE CLOTTING DUE TO THE AMOUNT OF TIME THE BLOOD PUMP WAS STOPPED. THE USER GUIDE INCLUDES INSTRUCTIONS FOR PERFORMING MANUAL RINSEBACK OF THE PATIENT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN EXTERNAL POWER FAILURE OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT PERFORMED DUE TO THE AMOUNT OF TIME THE BLOOD PUMP WAS STOPPED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S HGB ON (B)(6) 2010 WAS 12.6 G/DL AND DECREASED TO 10.9 G/DL ON (B)(6) 2011. THE PATIENT WHO WAS ON EPO HOLD AT THE TIME OF THE EVENT WAS RE-STARTED ON EPOGEN. NO OTHER MEDICAL INTERVENTION WAS REQUIRED FOR THE BLOOD LOSS.

    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 0107711

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other