BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2503627 · Received March 20, 2012

    Report

    Report Number
    3003464075-2012-00015
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    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

    FACILITY STAFF ATTRIBUTED THE ALARMS AND BLOOD LOSS TO THE OPERATOR NOT FOLLOWING INSTRUCTIONS PER THE USER'S GUIDE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO AIR IN THE EXTRACORPOREAL CIRCUIT. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. FACILITY STAFF HAS PROVIDED ADD'L TRAINING. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN ARTERIAL AIR ALARM AND VENOUS PRESSURE HIGH ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR WAS UNABLE TO RESOLVE THE ALARMS. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK OF THE PT'S BLOOD DUE TO THE AMOUNT OF TIME ELAPSED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PT'S HB WAS 9.5 G/DL ON (B)(6) 2012 AND DECREASED TO 8.3 G/DL ON (B)(6) 2012. STANDARD EPOGEN DOSING WAS INCREASED ON (B)(6) 2012 FROM 16,000 UNITS TO 20,000 UNITS. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other