BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2221613 · Received August 19, 2011

    Report

    Report Number
    3003464075-2011-00092
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 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 IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN AUDIBLE ALARM SOUNDED DURING A ROUTINE HEMODIALYSIS TREATMENT, WITH NO VISIBLE ALARM CODE. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK DUE TO THE AMOUNT OF TIME ELAPSED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT'S HGB WAS 11.3 G/DL ON (B)(6) 2011 AND DECREASED TO 7.5 G/DL ON (B)(6) 2011, (18 DAYS POST EVENT). THE PT'S STANDARD EPOGEN DOSE WAS INCREASED. EXACT DATE AND DOSING CHANGE NOT AVAILABLE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other