BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2234105 · Received August 29, 2011

    Report

    Report Number
    3003464075-2011-00094
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 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

    ARTERIAL PRESSURE ALARMS ARE TYPICALLY CAUSED BY INADEQUATE VASCULAR BLOOD FLOW TO MEET THE COMMANDED BLOOD PUMP FLOW RATE. THE REPORT DOES NOT CONTAIN INFO TO SUGGEST A DEVICE MALFUNCTION OCCURRED AND IS NOT CONSIDERED DEVICE RELATED. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. NO ADD'L ACTION IS REQUIRED AT THIS TIME. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ARTERIAL ACCESS PRESSURE ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, DUE TO CLOTTING OF THE ACCESS, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. HGB DECREASED FROM 10.4 G/DL ON (B)(6) 2011 TO 8.5 G/DL ON (B)(6) 2011. EPOGEN DOSING WAS RESUMED AT 2,000 UNITS TIW. 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 1057710

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other