BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 4536983 · Received February 23, 2015

    Report

    Report Number
    3003464075-2015-00002
    Event Type
    Injury
    Date Received
    February 23, 2015
    Date of Event
    January 27, 2015
    Report Date
    January 27, 2015
    Manufacturer
    NXSTAGE MEDICAL, INC
    Product Code
    KDI
    PMA / PMN Number
    K5050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED. THE HTN CONFIRMED THE PATIENT HAS HAD SIMILAR SYMPTOMS WITH PREVIOUS NON NXSTAGE TREATMENTS. THE PATIENT CONTINUES WITH TREATMENT AND NO FURTHER REPORTS OF THIS TYPE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A (B)(6) MALE PATIENT WHO EXPERIENCED A RASH, ODD TASTE AND CHEST TIGHTNESS DURING TREATMENT. FOLLOW UP WITH THE HOME HEMODIALYSIS NURSE CONFIRMED NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS INSTRUCTED TO FLUSH THE SYSTEM WITH SALINE PRIOR TO TREATMENT. THE PATIENT EXPERIENCED THE SAME ISSUES WHEN IN TREATMENT AT THE CENTER USING NON-NXSTAGE EQUIPMENT. THE PATIENT CONTINUES TO USE NXSTAGE PRODUCT WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126472 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC CAR-170-C NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other