BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6067479 · Received October 31, 2016

    Report

    Report Number
    3003464075-2016-00042
    Event Type
    Injury
    Date Received
    October 31, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 5, 2016
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K122051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LOG FILES WERE NOT AVAILABLE FOR EVALUATION. THE AVAILABLE INFORMATION DOES NOT INDICATE THAT THERE WAS A DEVICE MALFUNCTION. THE SERIAL NUMBER WAS NOT PROVIDED AND NO LOG FILES WERE AVAILABLE FOR REVIEW. THE USER GUIDE PROVIDES INFORMATION FOR PERFORMING RINSE-BACK AND STATES A TRAINED AND QUALIFIED OBSERVER MUST PAY CLOSE ATTENTION TO THE BLOOD LINE AND ACCESS CONNECTIONS, ESPECIALLY WHEN THE PATIENT IS CONNECTED AND DISCONNECTED. IN ADDITION, THE USER GUIDE STATES THAT BLOOD REMAINING IN LINES AFTER RINSEBACK MAY LEAD TO BLOOD LOSS AND THAT THE USER SHOULD FOLLOW CENTER¿S INSTRUCTIONS FOR RINSING BACK BLOOD AT THE END OF TREATMENT. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 5-OCTOBER-2016 OF A (B)(6) FEMALE PATIENT WHO, AFTER COMPLETING A ROUTINE HOME HEMODIALYSIS TREATMENT CONNECTED THE VENOUS PATIENT BLOOD LINE TO THE SALINE BAG INSTEAD OF THE ARTERIAL PATIENT BLOODLINE RESULTING IN AN ESTIMATED BLOOD LOSS OF 450ML. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016 FOR APPROXIMATELY ONE WEEK. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719224 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. NX1000-3

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization