BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 8723520 · Received June 21, 2019

    Report

    Report Number
    3003464075-2019-00029
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 21, 2019
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    M535CAR172C0
    PMA / PMN Number
    K140526
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED CARTRIDGE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED WHICH CONFIRMED THAT THE PRODUCT MET 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. THIS REPORT AND THE INFORMATION CONTAINED HEREIN IS SUBMITTED TO THE APPLICABLE COMPETENT AUTHORITY UNDER MEDICAL DEVICE DIRECTIVE 93/42/EEC AND REPRESENTS THE INFORMATION AVAILABLE TO THE COMPANY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 07 JUN 2019 FROM THE PHYSICIAN REGARDING A (B)(6) MALE, WITH A RECENT HISTORY OF RESPIRATORY DIFFICULTY DURING HEMODIALYSIS TREATMENT, WHO EXPERIENCED RESPIRATORY DIFFICULTY, CHEST PAIN, TREMOR, AND TINGLING LIPS AT THE TIME OF CONNECTION DURING THEIR SECOND HEMODIALYSIS TREATMENT WITH THE NXSTAGE SYSTEM ON (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 FROM A PHARMACIST STATING TREATMENT WAS TERMINATED AFTER APPROXIMATELY 50 MINUTES AND THE PATIENT WAS TREATED WITH ORAL POLARAMINE (DOSE UNSPECIFIED). THE PATIENT RECOVERED WITHOUT SEQUELAE AND HAS DISCONTINUED RECEIVING HEMODIALYSIS TREATMENT USING NXSTAGE PRODUCT AND THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517700 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-172-C 80277035 M535CAR172C0

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other