BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3775412 · Received April 18, 2014

    Report

    Report Number
    3003464075-2014-00007
    Event Type
    Death
    Date Received
    April 18, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE PT'S DEATH CANNOT BE DETERMINED. THE EXTRACORPOREAL CARTRIDGE WAS DISPOSED OF AND THE LOT NUMBER WAS NOT PROVIDED. THE CARTRIDGE IFU STATES: DO NOT USE THE CARTRIDGE FOR MORE THAN 72 HOURS OR 864 LITERS OF BLOOD PROCESSED. ADDITIONALLY PER THE USER'S GUIDE WHEN THE CAUTION 70 OCCURS, THE CARTRIDGE SHOULD BE CHANGED OUT. NO FURTHER INVESTIGATION CAN BE PERFORMED. NXTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT WITH COPD, HYPERTENSION, TYPE II DIABETES, AND ACUTE KIDNEY INJURY WAS ADMITTED TO ICU FROM THE EMERGENCY ROOM ON (B)(6) 2014. PT STARTED ON CVVHD ON (B)(6) 2014 WITHOUT INCIDENT. CARTRIDGE CHANGE OCCURRED ON (B)(6) 2014. ON (B)(6) 2014 AT 6:41, A CAUTION 70 OCCURRED INDICATING THE CARTRIDGE LIFE EXPECTANCY HAD BEEN EXCEEDED. TREATMENT WAS ENDED AT 7:33 ON (B)(6) 2014 AND THE PT'S BLOOD WAS RETURNED. DURING THE 52 MINUTES OF THE CAUTION 70, THE BLOOD PUMP CONTINUED TO RUN HOWEVER FILTERING OF THE PT'S BLOOD PUMP CONTINUED TO RUN; HOWEVER, FILTERING OF THE PT'S BLOOD HAD DISCONTINUED. THE PT RAPIDLY BECAME HYPOTENSIVE, MOTTLED AND CODED. THE BLOOD IN THE DIALYSATE LINES WAS NOTED AS SEPARATED. THE PT EXPIRED AFTER TREATMENT WAS DISCONTINUED (OTHERWISE UNSPECIFIED). THE PHYSICIAN BELIEVES THIS EVENT TO BE A COMPLEMENT MEDIATED REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239032 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death