BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2772048 · Received September 28, 2012

    Report

    Report Number
    3003464075-2012-00072
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 1, 2012
    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 REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS DIRECTED. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS, AS WELL AS INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK OF THE PT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. HB DECREASED FROM 11.1 G/DL ON (B)(6) 2012 TO 9.4 G/DL ON (B)(6) 2012. STANDARD EPOGEN DOSING WAS INCREASED ON (B)(6) 2012 FROM 10,600 1XWEEK TO 12,800 1XWEEK. 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-C 2067705

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other