BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 10439148 · Received August 21, 2020

    Report

    Report Number
    3003464075-2020-00055
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    July 27, 2020
    Report Date
    August 21, 2020
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    UDI-DI
    M535CAR5050
    PMA / PMN Number
    K133547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED A SIMILAR ADVERSE EVENT WITH THE SAME DEVICE MODEL NUMBER IN (B)(6) 2019 (DATE NOT PROVIDED). THE EVENT IS DOCUMENTED IN MFR REPORT # 3003464075-2020-00054. 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. THE INSTRUCTIONS FOR USE WARN THAT THE DEVICE MUST BE USED UNDER THE PRESCRIPTION OF A PHYSICIAN. 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. MONITORING OF THE PATIENT SHOULD BE PERFORMED REGULARLY TO ENSURE AN APPROPRIATE RESPONSE TO THERAPY. BIOCOMPATABILITY HAS BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 30 JUL 2020 FROM THE PHYSICIAN OF A (B)(6) YEAR OLD MALE IN CRITICAL CARE FOR TREATMENT OF PERICARDIAL EFFUSION AND FLUID OVERLOAD, WITH MULTIPLE COMORBIDITIES INCLUDING KNOWN DIALYZER REACTIONS DURING DIALYSIS THERAPY, WHO EXPERIENCED SYMPTOMS 10 ¿ 15 MINUTES INTO CONTINUOUS RENAL REPLACEMENT THERAPY ON (B)(6) 2020. SYMPTOMS INCLUDED CHANGE OF TASTE, TACHYPNEA, LABILE PULSE, HYPOXIA, HYPERTENSION, AND ANXIETY. ADDITIONAL INFORMATION WAS RECEIVED ON 5 AUG 202 FROM THE PHYSICIAN STATING THE PATIENT¿S OXYGEN LEVEL DROPPED FROM ~90% TO 67%, SYSTOLIC BLOOD PRESSURE INCREASED FROM 100MMHG TO 144MMHG, HEART RATE INCREASED FROM 110BPM TO 140BPM AND RESPIRATORY RATE INCREASED FROM ~30 TO 40/M. 25MG BENADRYL WAS ADMINISTERED INTRAVENOUSLY TO ADDRESS THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904672 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-505 00478027 M535CAR5050

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other