BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6073059 · Received November 2, 2016

    Report

    Report Number
    3003464075-2016-00043
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 14, 2016
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K133547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED FOR INVESTIGATION. ALL AVAILABLE INFORMATION SUPPORTS THAT THE PRODUCT WAS FUNCTIONING AS DESIGNED AND THERE WAS NO MALFUNCTION. BIOCOMPATIBILITY OF THE DEVICE HAS BEEN ESTABLISHED. THE USER GUIDE INCLUDES ALLERGIC REACTION AS A POTENTIAL RISK ASSOCIATED WITH DIALYSIS TREATMENTS AND ALSO INCLUDES WARNINGS TO MONITOR FOR POTENTIAL ALLERGIC REACTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2016 OF AN ADULT MALE WHO EXPERIENCED RESPIRATORY ARREST, HYPOTENSION AND BRADYCARDIA WHEN CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) COMMENCED ON (B)(6) 2016 IN INTENSIVE CARE. THE PATIENT WAS INTUBATED AND ADVANCED CARDIAC LIFE SUPPORT PROTOCOL (ACLS) WAS INITIATED. THE PATIENT STABILIZED. ON (B)(6) 2016 CRRT AGAIN COMMENCED AND THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. TREATMENT WAS DISCONTINUED AND THE PATIENT STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722923 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 60878004

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R