BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3012332 · Received March 15, 2013

    Report

    Report Number
    3003464075-2013-00013
    Event Type
    Death
    Date Received
    March 15, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION AND THE INSTRUCTIONS FOR USE CONTAIN ADEQUATE WARNINGS TO USE ONLY AFTER OPENING THE PEEL SEAM AND MIXING THE TWO SOLUTIONS AND THAT APPROPRIATE MONITORING OF PT'S HEMODYNAMIC, FLUID, ELECTROLYTE AND ACID-BASE BALANCE SHOULD BE PERFORMED. NXSTAGE MEDICAL CONSIDERS THIS CASE CLOSED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON (B)(4) 2013 FROM A CHARGE NURSE IN AN ACUTE DIALYSIS UNIT REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6) WHO WAS ON CRRT POST OPEN HEART SURGERY. THE NURSE STATED THE PT HAD MULTIPLE MEDICAL ISSUES AND WAS NOT EXPECTED TO RECOVER. CVVHD WAS INITIATED. THE REPORTER STATED THAT DURING TREATMENT, THE NURSE HAD NOT OPENED THE PEEL SEAM AND MIXED THE TWO SOLUTIONS IN THE DIALYSATE BAGS. THE PT HAD DIALYZED WITH THE UNMIXED DIALYSATE FOR AN ESTIMATED TWO AND HALF HOURS. CVVHD THERAPY WAS DISCONTINUED BECAUSE NO IMPROVEMENT. NO LABS WERE DRAWN POST TREATMENT AND ON (B)(6) 2013 THE PT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110961 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. RFP-400-B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death