BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2133670 · Received June 9, 2011

    Report

    Report Number
    3003464075-2011-00072
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO THE PRESENCE OF AIR. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. FACILITY STAFF HAVE BEEN NOTIFIED AND PROVIDED ADDITIONAL REVIEW OF ALARM RECOVERY. THERE HAVE BEEN NO SUBSEQUENT SIMILAR PROBLEMS REPORTED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN ARTERIAL AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK OF THE PT'S BLOOD, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT'S HGB DECREASED FROM 10.0 G/DL PRE EVENT TO 9.1 G/DL ON (B)(6) 2011. STANDARD EPOGEN DOSE WAS INCREASED FROM 6,000 UNITS 1 X WEEK TO 8,000 UNITS 1 X WEEK. 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 74 YR Other