BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1903510 · Received November 16, 2010

    Report

    Report Number
    3003464075-2010-00114
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED TO NXSTAGE FOR EVAL. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED WITH THIS LOT OF DIALYSATE SAKS. THE PT REPORTED NOT FEELING WELL PRIOR TO THE START OF TREATMENT. THE PT BLOOD CULTURES WERE NEGATIVE. IT IS SUSPECTED THAT THE DIALYSATE SPECIMEN MAY HAVE BEEN CONTAMINATED BY THE COLLECTOR OF THE SPECIMEN. THE USER GUIDE INCLUDES ADEQUATE WARNINGS AND INSTRUCTIONS REGARDING THE USE OF ASEPTIC TECHNIQUE WHEN MAKING SAK AND CARTRIDGE CONNECTIONS. DIALYSATE MUST PASS THROUGH A 1.2 MICRON FILTER PRIOR TO ENTERING THE CARTRIDGE. ADDITIONALLY, THE DIALYZER ITSELF WITH AN AVERAGE PORE SIZE OF 0.007 MICRONS MAINTAINS SEPARATION BETWEEN THE BLOOD STREAM AND ANY ALLEGED CONTAMINATION IN THE DIALYSATE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT REPORTED NOT FEELING WELL PRIOR TO INITIATION OF ROUTINE HEMODIALYSIS TREATMENT. WITHIN 30 MINUTES AFTER TREATMENT STARTED, THE PT SPIKED A FEVER AND HAD CHILLS. THE TREATMENT WAS ENDED AND THE PT WAS ADMITTED TO HOSPITAL. FACILITY NURSE REPORTS PT WAS ADMITTED ON (B)(6), AND DISCHARGED ON (B)(6). BLOOD CULTURES WERE NEGATIVE. PER NURSE, PHYSICIAN DIAGNOSIS WAS PANCYTOPENIA. DIALYSATE CULTURES DRAWN BY NURSE ON (B)(6) 2010, WERE POSITIVE FOR PSEUDOMONAS AERUGINOSA. PT WAS TREATED WITH IV LEVAQUIN AND DISCHARGED ON ORAL LEVAQUIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization