BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2142368 · Received June 21, 2011

    Report

    Report Number
    3003464075-2011-00077
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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 REPORTED SYS ALARM COULD NOT BE CONFIRMED AS THE CARTRIDGE WAS NOT RETURNED FOR EVAL AS REQUESTED. THE PT WILL BE SEEING A VASCULAR SURGEON DUE TO STENOSIS OF FISTULA. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THE USER GUIDE ALSO INCLUDES INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK OF THE PT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THESE EVENTS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    RINSEBACK OF THE PT'S BLOOD WAS NOT PERFORMED DURING A ROUTINE HEMODIALYSIS TREATMENT DUE TO AN UNRECOVERABLE SYS ALARM DURING THE TREATMENT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. FACILITY NURSE REPORTS RINSEBACK NOT PERFORMED DUE TO FISTULA STENOSIS FOLLOWING ANOTHER TREATMENT IN EARLY JUNE, EXACT DATE NOT PROVIDED. THE PT'S HGB LEVEL WAS EVALUATED AFTER THE SECOND EVENT AND HAD DECREASED APPROX 1.5 TO 2 UNITS TO 8.6 G/DL. ROUTINE EPOGEN PRESCRIPTION WAS INCREASED FROM 15,000 UNITS TO 30,000 UNITS 2X/WEEK AND THE PT WAS GIVEN IRON. 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 0107712

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other