BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 8666953 · Received June 4, 2019

    Report

    Report Number
    3003464075-2019-00023
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 4, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K140526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CARTRIDGE WAS RETURNED FOR EVALUATION AND A LOT NUMBER WAS NOT PROVIDED. THE PRODUCT MEETS ALL QUALITY CRITERIA AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE IS NO INFORMATION TO INDICATE THAT A MALFUNCTION OCCURRED. ALLERGIC OR ADVERSE REACTIONS ARE KNOWN RISKS OF HEMODIALYSIS. THE NXSTAGE USER GUIDE AND INSTRUCTIONS FOR USE INCLUDE ALLERGIC REACTION AS A POTENTIAL RISK ASSOCIATED WITH DIALYSIS THERAPY AND ALSO INCLUDE WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. BIOCOMPATABILITY HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 13 MAY 2019 FROM THE HOME THERAPY NURSE (HTN) REGARDING A (B)(6) FEMALE WHO BECAME SYMPTOMATIC APPROXIMATELY 5-10 MINUTES INTO HER FIRST HEMODIALYSIS TREATMENT USING THE NXSTAGE SYSTEM ON (B)(6) 2019. SYMPTOMS INCLUDED CHEST DISCOMFORT, BACK PAIN, DECREASED OXYGEN SATURATION, HYPERTENSION, INCREASED HEART RATE, FEELING COLD AND SHIVERING, WHICH RESOLVED IN APPROXIMATELY 45 MINUTES WITH ADMINISTRATION OF NASAL OXYGEN. NO OTHER TREATMENT WAS REQUIRED, AND THE PATIENT CONTINUES TO PERFORM THERAPY WITH THE NXSTAGE SYSTEM USING A DIALYZER FROM A DIFFERENT MANUFACTURER. PRE-TREATMENT VITALS: BP: 182/107, HR: 86, TEMPERATURE: 36.1C. DURING TREATMENT VITALS (WHILE SYMPTOMATIC): DECREASED OXYGEN SATURATION: 64-78%, BP: 206/113, HR: 96-99, TEMPERATURE: 36.2C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460632 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-172-C

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other