BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3330441 · Received August 30, 2013

    Report

    Report Number
    3003464075-2013-00032
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    August 3, 2013
    Report Date
    August 5, 2013
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD CULTURES DRAWN DURING INPATIENT STAY WERE NEGATIVE. NO PRODUCT WAS RETURNED TO NXSTAGE FOR EVALUATION. NO PRODUCT AS RETURNED TO NXSTAGE FOR EVALUATION. NO SIMILAR PROBLEMS ARE WITH THIS LOT OF DIALYSATE SAKS. 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 A SEPARATION BETWEEN THE BLOOD STREAM AND ANY ALLEGED CONTAMINATION IN THE DIALYSATE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED. THIS REPORT AND THE INFO CONTAINED HEREIN IS SUBMITTED TO THE FOOD AND DRUG ADMINISTRATION UNDER 21 CFR PART 803 AND REPRESENTS THE INFO AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    PT WAS ADMITTED ON (B)(6) 2013 WITH FEVER/CHILLS AFTER COMPLAINT OF THESE SYMPTOMS FOR THE PREVIOUS TWO WEEKS. BLOOD/URINE CULTURES DRAWN DURING THIS PERIOD WERE REPORTED TO BE NEGATIVE. PT WAS ALSO TREATED WITH TYLENOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431172 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-304 3057918

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization