BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1953439 · Received December 30, 2010

    Report

    Report Number
    3003464075-2010-00152
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 1, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS SHOWED THAT THE USER HAD INCREASED THE UFR TO 999 ML/HR AT 1:56 AM; THEN REDUCED IT TO 0 AT 3:18 AM. THE INITIAL UFR WAS SET AT 100 ML/HR. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED EVENT IS ATTRIBUTED TO USE ERROR. FACILITY STAFF WILL BE PROVIDING ADD'L TRAINING. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A CVVH TREATMENT, THE PT BECAME HYPOTENSIVE. THE TREATMENT PARAMETERS WERE REVIEWED AND DETERMINED THAT THE ULTRAFILTRATION RATE WAS INCORRECT. THE PATIENT REQUIRED 1.5L NORMAL SALINE FLUID RESUSCITATION AND TITRATION OF VASOPRESSORS; ONE UNIT OF PRBC'S WAS ALSO ADMINISTERED, PATIENT HAD BEEN RECEIVING BLOOD PRODUCTS PRIOR TO EVENT. FACILITY STAFF SUSPECTED AN OPERATOR KEY PRESS ERROR WHICH WAS CONFIRMED THROUGH CYCLER LOG FILE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention