BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2132596 · Received June 10, 2011

    Report

    Report Number
    3003464075-2011-00073
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 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 BLOOD LOSS IS ATTRIBUTED TO POSSIBLE CLOTTING DUE TO THE AMOUNT OF TIME THE BLOOD PUMP WAS STOPPED. IN THE EVENT OF AN EXTERNAL POWER OUTAGE, THE USER'S GUIDE INCLUDES INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK WHEN TRAINED AND INSTRUCTED BY THE FACILITY, TO RETURN THE PATIENT'S BLOOD WITH NO IMPACT TO PATIENT SAFETY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN EXTERNAL POWER OUTAGE OCCURRED APPROXIMATELY 20 MINUTES INTO 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. PROCRIT WAS INCREASED FROM 10,000 UNITS TO 14,000 UNITS. THE PATIENT'S HGB WAS 9.1 G/DL ON (B)(6) 2011 AND 8.8 G/DL ON (B)(6) 2011. 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 1037721

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other