BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 16875877 · Received May 5, 2023

    Report

    Report Number
    3003464075-2023-00039
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 5, 2023
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAK WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. ALL DEVICES MUST MEET QUALITY REQUIREMENTS AND MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE NXSTAGE SYSTEM ONE USER GUIDE OUTLINES RISKS ASSOCIATED WITH PERFORMING HEMODIALYSIS THERAPY AND WARNS THAT TREATMENT SHOULD ONLY BE PERFORMED BY A TRAINED AND QUALIFIED PERSON WHO MUST RESPOND PROMPTLY TO HARMFUL CONDITIONS DURING TREATMENT.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) OF A 44 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED NUMBNESS ON THEIR LEFT SIDE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HTN WHO STATED THE PATIENT ALSO EXPERIENCED DIZZINESS, PRESSURE IN THEIR CHEST, PALPITATIONS, AND FELT UNWELL (NOS). TREATMENT WAS TERMINATED WITH RINSEBACK AND THE PATIENT PRESENTED TO THE HOSPITAL WITH HYPERKALEMIA (NOS) AND WAS ADMITTED FOR OBSERVATION AND TESTING. THE PATIENT RECEIVED HEMODIALYSIS TREATMENT WITH NO ADDITIONAL MEDICAL INTERVENTION BEING REQUIRED AND WAS DISCHARGED (B)(6) 2023. FOLLOWING THE EVENT THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND RESUMED TREATMENT WITH THE NXSTAGE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629982 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-404

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Hospitalization