BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 4289113 · Received November 26, 2014

    Report

    Report Number
    3003464075-2014-00023
    Event Type
    Death
    Date Received
    November 26, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED SAK AND CARTRIDGE DID NOT INDICATE A PRODUCT MALFUNCTION. THE CYCLER WILL BE EVALUATED UPON RETURN.

    Additional Manufacturer Narrative · 1

    BASED ON THE EVALUATIONS PERFORMED TO DATE ON THE CARTRIDGE, SAK, AND CYCLER, THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OR PRODUCT DEFICIENCY WAS PRESENT OR CONTRIBUTED TO THE DEATH OF THE PATIENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, THE PT "WENT OUT" ACCORDING TO THE CAREGIVER. THE CENTER HOME THERAPY NURSE WAS ON THE PHONE WITH THE CAREGIVER AND INSTRUCTED HER TO GIVE A SALINE BOLUS. THE CENTER CALLED 911. THE EMERGENCY MEDICAL TEAM ARRIVED; HOWEVER, THE PT HAD EXPIRED. A CAUSE OF DEATH WAS NOT ESTABLISHED AND THE CENTER REPORTED IT WAS UNK IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769428 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYS KDI NXSTAGE MEDICAL, INC. CYC-D2E

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death