BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1781285 · Received July 28, 2010

    Report

    Report Number
    3003464075-2010-00069
    Event Type
    Injury
    Date Received
    July 28, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 29, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEM FOUND WITH RETURNED CARTRIDGE. NO EVIDENCE OF DEVICE MALFUNCTION. LOGFILE ANALYSIS INDICATES HIGH VENOUS PRESSURES AT THE START OF THE DIALYSIS TREATMENT. THE BLOOD PUMP WAS OFF FOR 11 MINUTES DURING THE FIRST 30 MINUTES OF THE TREATMENT AS A RESULT OF MULTIPLE HIGH VENOUS PRESSURE ALARMS AND DECREASING EFFLUENT PRESSURE ALARMS THAT WERE NOT RESOLVED. THE USER'S GUIDE WARNS THAT THE RISK OF CLOTTING INCREASES WHEN BLOOD FLOW IS STOPPED AND FAILURE TO RESPOND TO CLOTTING MAY LEAD TO HEMOLYSIS. THE USER'S GUIDE ALSO INSTRUCTS TO DISCONTINUE TREATMENT IF ALARMS CANNOT BE RESOLVED PROMPTLY. FACILITY STAFF HAVE PROVIDED ADDITIONAL TRAINING. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A ROUTINE HEMODIALYSIS TREATMENT WAS DISCONTINUED WITHOUT RINSEBACK OF THE PATIENT'S BLOOD DUE TO CLOTTING OF THE EXTRACORPOREAL BLOOD CIRCUIT. APPROXIMATELY, ONE HOUR AFTER DISCONTINUING THE DIALYSIS TREATMENT, PATIENT COMPLAINED OF CHEST PAIN, HEMATURIA, AND INCREASED BLOOD PRESSURE. PATIENT WENT TO HOSPITAL EMERGENCY DEPARTMENT. PATIENT HEMOGLOBIN HAD DECREASED TO 10 FROM A VALUE THE WEEK PRIOR OF 12. PATIENT WAS HOSPITALIZED FOR 24 HOURS FOR OBSERVATION. A DIALYSIS TREATMENT COULD NOT BE PERFORMED WHILE IN THE HOSPITAL BECAUSE THE PATIENT'S VENOUS ACCESS WAS INFILTRATED. PATIENT WAS DISCHARGED ON (B)(6)2010. NO SPECIFIC MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-124-C 0017710

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization LOT #C409118801| GAMBRO REVACLEAR HEMODIALYSIS FILTER