BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3890484 · Received June 12, 2014

    Report

    Report Number
    3003464075-2014-00012
    Event Type
    Death
    Date Received
    June 12, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAD A CARDIAC ARREST DURING HEMODIALYSIS TREATMENT. FOLLOW UP REQUESTS WITH THE REPORTING NURSE FOR CAUSALITY WERE NOT RESPONDED TO. NO PRODUCTS WERE RETURNED FOR EVALUATION. 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. THE REPORT DOES NOT CONSTITUTE AN ACKNOWLEDGEMENT THAT THE EVENTS HEREIN OCCURRED.

    Description of Event or Problem · 1

    THE HOME TRAINING NURSE REPORTED THE PT WAS FOUND UNRESPONSIVE BY THE CAREGIVER ON (B)(6) 2014 DURING A ROUTINE HEMODIALYSIS TREATMENT. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. THE HTN STATED THAT THE PT HAD A CARDIAC ARREST DURING TREATMENT. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348219 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTO KDI NXSTAGE MEDICAL, INC. CAR-170-C NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death