BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2112311 · Received May 24, 2011

    Report

    Report Number
    3003464075-2011-00061
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    February 6, 2011
    Report Date
    April 25, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON REVIEW OF THE CYCLER TREATMENT DATA LOG FILE THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER UF PUMP RATE IS ADJUSTED BY THE OPERATOR TO ACCOUNT FOR EXTERNAL FLUIDS AND MEDICATION GIVEN TO THE PT TYPICALLY ADMINISTERED VIA EXTERNAL INFUSION PUMPS. TYPICAL ACCURACY OF THESE EXTERNAL DEVICES IS ABOUT 10%. LOG FILE ANALYSIS INDICATED THAT THE CYCLER UF PUMP RATE WAS CHANGED FREQUENTLY BY THE OPERATOR. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO FREQUENT CHANGES TO PUMP RATES AT IRREGULAR INTERVALS WHICH RESULTED IN AN INCREASED LIKELIHOOD OF OPERATOR CALCULATION ERRORS IN MANAGING PT FLUID INPUT/OUTPUT. DEVICE LABELING CONTAINS ADEQUATE WARNINGS REGARDING WEIGHING THE PT TO CONFIRM FLUID BALANCE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    CVVHD WAS INITIATED (B)(6) 2011 ON AN ICU PT ADMITTED WITH SEIZURES, HYPOGLYCEMIA AND UNRESPONSIVE. CVVHD STOPPED ON (B)(6) 2011 AND THEN RESTARTED ON (B)(6) 2011. NURSES WERE ATTEMPTING TO RUN THE PT EUVOLEMIC. PT WAS WEIGHED ON A DAILY BASIS. PT WEIGHT WAS 2.0 KG LESS THAN EXPECTED BETWEEN WEIGHINGS ON (B)(6) 2011 AT 0500 AND (B)(6) 2011 AT 2300. PT EXPERIENCED A DECREASE IN BLOOD PRESSURE AND URINE OUTPUT CEASED. PT WAS ADMINISTERED 25% ALBUMIN AND NORMAL SALINE. CVVHD WAS CONTINUED WITH NO ADDITIONAL SIMILAR PROBLEMS AND PT IMPROVED. NO OTHER 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. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention