BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6526662 · Received April 27, 2017

    Report

    Report Number
    3003464075-2017-00026
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    March 26, 2017
    Report Date
    April 27, 2017
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. A LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, NO DEVICE HISTORY REVIEW (DHR) COULD BE PERFORMED. THERE IS NO INDICATION THAT THE DEVICE WAS RELATED TO THE REPORTED EVENT. THE USER GUIDE WARNS: HEMODIALYSIS MAY RESULT IN SIGNIFICANT CHANGES IN THE BLOOD CONCENTRATION OF ELECTROLYTES AND GLUCOSE AND IN THE PATIENT¿S VOLUME STATUS. APPROPRIATE MONITORING OF THE PATIENT¿S HEMODYNAMIC, FLUID, ELECTROLYTE, AND ACID-BASE BALANCE SHOULD BE PERFORMED REGULARLY, PER PHYSICIAN ORDERS, TO ENSURE APPROPRIATE RESPONSE TO THERAPY. FAILURE TO DO SO COULD RESULT IN INAPPROPRIATE THERAPY FOR THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2017 FROM THE CAREGIVER OF A (B)(6) MALE PATIENT WITH AN ONGOING HISTORY OF HYPERKALEMIA, WHO HAD RECEIVED STANDARD HOME HEMODIALYSIS TREATMENT ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT EXPERIENCED WEAKNESS, SHORTNESS OF BREATH AND SHAKING. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND EXPERIENCED A CARDIAC ARREST ENROUTE. HE WAS ADMITTED AND REMAINED HOSPITALIZED UNTIL (B)(6) 2017 WHEN HE WAS TRANSFERRED TO A REHABILITATION FACILITY UNTIL (B)(6) 2017. THE PATIENT WAS RELEASED FROM THE REHABILITATION FACILITY IN STABLE CONDITION, RETURNING TO STANDARD HOME HEMODIALYSIS. A DISCHARGE DIAGNOSIS WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307045 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-404

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L