BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2435773 · Received January 27, 2012

    Report

    Report Number
    3003464075-2012-00006
    Event Type
    Injury
    Date Received
    January 27, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO AIR IN THE CIRCUIT. FACILITY STAFF ATTRIBUTED THE ALARMS AND BLOOD LOSS TO USE ERROR AND HAS PROVIDED ADD'L TRAINING TO THE OPERATOR. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    VENOUS AIR ALARMS OCCURRED WITHIN 13 DAYS DURING TWO ROUTINE HEMODIALYSIS TREATMENTS. AIR WAS VISIBLE IN THE BLOOD LINE. TREATMENTS WERE DISCONTINUED W/O PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH TREATMENT. THE PT'S HB, WHICH TYPICALLY RUNS LOW DECREASED FROM 8.9 G/DL ON (B)(6) 2011 TO 8.3 G/DL ON (B)(6) 2012. EPOGEN WAS INCREASED 19 DAYS AFTER THE FIRST BLOOD LOSS FROM 20,000 UNITS 1X/WK TO 30,000 UNITS 1X/WK. NO ADD'L 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 1117735

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other