BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 10083032 · Received May 22, 2020

    Report

    Report Number
    3003464075-2020-00026
    Event Type
    Death
    Date Received
    May 22, 2020
    Date of Event
    April 3, 2020
    Report Date
    June 16, 2020
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND EVALUATED AND WAS FOUND TO BE FUNCTIONING AS DESIGNED AND INTENDED. THE LOG FILE FOR THE TREATMENT WAS ANALYZED AND FINDINGS SHOWED THAT AT THE TIME OF THE EVENT THE PRIME AND ALARM TEST WAS STILL IN PROGRESS. DURING THE PRIME AND ALARMS TEST SOME SAFETY SYSTEMS, INCLUDING AIR ALARMS, ARE INACTIVE TO ALLOW THE USER TO EXPEL AIR FROM THE EXTRACORPOREAL CIRCUIT. THE NXSTAGE SYSTEM ONE USER GUIDE WARNS TO NEVER CONNECT THE PATIENT TO THE CARTRIDGE BEFORE YOU SEE THE TREATMENT PARAMETERS IN THE NXSTAGE SYSTEM ONE CYCLER¿S WINDOW, WHICH INDICATES THAT THE PRIME AND ALARMS TEST IS COMPLETED. THERE WAS NO DEVICE MALFUNCTION. THE AVAILABLE INFORMATION IS CONSISTENT WITH A USE ERROR AND THE DIAGNOSIS OF AIR EMBOLISM PROVIDED BY THE PHYSICIAN. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 24 APR 2020 FROM THE HOME THERAPY NURSE (HTN) REGARDING A (B)(6) YEAR OLD FEMALE WITH AN EXTENSIVE MEDICAL HISTORY WHO BECAME DIZZY AND UNRESPONSIVE AFTER TROUBLESHOOTING ALARMS AND TERMINATING HEMODIALYSIS TREATMENT WITH RINSEBACK ON (B)(6) 2020. 911 WAS CALLED AND THE PATIENT WAS TRANSPORTED TO HOSPITAL WHERE SHE SUBSEQUENTLY EXPIRED ON (B)(6) 2020. ADDITIONAL INFORMATION WAS RECEIVED 29 APR 2020 FROM THE HTN WHICH SHOWED RESUSCITATION MEASURES INCLUDED INTUBATION AND EPINEPHRINE (ROUTE NOT SPECIFIED). AFTER ARRIVING AT THE HOSPITAL THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A CT SCAN REVEALED AN AIR EMBOLISM IN THE BRAIN. THE HOSPITAL COURSE INVOLVED THE PATIENT BEING MECHANICALLY VENTILATED FOR ACUTE RESPIRATORY FAILURE SECONDARY TO THE ANOXIC BRAIN INJURY AND AN ACUTE BIFRONTAL LOBE EMBOLIC CEREBROVASCULAR ACCIDENT (CVA). THE PATIENT REMAINED UNRESPONSIVE AND AREFLEXIC AND WAS GIVEN A POOR PROGNOSIS. THEIR CONDITION WORSENED DUE TO SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, BRAIN INJURY, ACUTE ENCEPHALOPATHY AND SEIZURES. THE PATIENT WAS EXTUBATED ON (B)(6) 2020, PLACED ON COMFORT CARE AND EXPIRED AT 21:45HRS ON (B)(6) 2020 WITH CARDIAC ARREST REPORTED AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546920 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H