BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6375935 · Received March 3, 2017

    Report

    Report Number
    3003464075-2017-00012
    Event Type
    Death
    Date Received
    March 3, 2017
    Date of Event
    February 7, 2017
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETAINED FOR INVESTIGATION. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED AND NO DEFECTS WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT. BIOCOMPATIBILITY HAS BEEN ESTABLISHED. THERE IS NO INFORMATION TO INDICATE THAT A MALFUNCTION OCCURRED. THE NXSTAGE USER GUIDE PROVIDES WARNING TO ALWAYS USE ASEPTIC TECHNIQUE WHEN HANDLING CONNECTIONS. TOUCHING THESE SURFACES MAY MAKE THEM NON-STERILE, WHICH MAY CAUSE PATIENT INFECTION. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S HOME THERAPY NURSE THAT A (B)(6) FEMALE PATIENT WAS TREATING IN CENTER ON (B)(6) 2017. APPROXIMATELY 2 HOURS AFTER TREATMENT COMMENCED, THE PATIENT DEVELOPED FEVER AND CHILLS. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS ADMITTED ON (B)(6) 2017. THE PHYSICIAN DOCUMENTED IN THE MEDICAL RECORDS THAT THE PATIENT WAS VERY UNSTABLE, UNRESPONSIVE, WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION. THE PATIENT WAS HYPOTENSIVE REQUIRING THREE "PRESSORS" (VASOPRESSORS), RECEIVED BLOOD TRANSFUSIONS (UNSPECIFIED), WAS TREATED WITH ANTIBIOTICS AND WAS PLACED ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). ADDITIONAL DOCUMENTATION BY THE PHYSICIAN STATED THAT THE PATIENT HAD SEVERE SEPSIS SECONDARY TO CITROBACTER KOSERI, LIKELY ASSOCIATED WITH THE RIGHT (R) RENAL STONES AND COLITIS SEEN IN CT IMAGING. THE PHYSICIAN HAD NOTED THERE WAS BLEEDING FROM THE RIGHT FEMORAL VASCATH AND THIS MAY HAVE BEEN A SECONDARY SOURCE OF INFECTION. THE PHYSICIAN RECOMMENDED REMOVAL OF THE FEMORAL LINE. THE PATIENT DIED IN THE HOSPITAL ON (B)(6) 2017. THE NURSE REPORTED THAT THE CAUSE OF DEATH WAS SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159060 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-301 60679273

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| L| R