BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1140955 · Received August 28, 2008

    Report

    Report Number
    3003464075-2008-00400
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROBLEMS FOUND WITH THE RETURNED CARTRIDGE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. FACILITY STAFF ATTRIBUTED THE PT'S SYMPTOMS TO A POSSIBLE DIALYZER REACTION. PT IS NOW DIALYZING USING SYSTEM ONE WITH A DIFFERENT MANUFACTURER'S DIALYZER AND NO SIMILAR PROBLEMS HAVE OCCURRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT AT THE VERY START OF A ROUTINE HEMODIALYSIS TREATMENT FOLLOWING A DIFFICULT CANNULATION, THE PT COMPLAINED OF ABDOMINAL PAIN AND LOST CONSCIOUSNESS. TREATMENT WAS DISCONTINUED WITHOUT RINSEBACK OF THE PT'S BLOOD WHICH HAD JUST FILLED THE CARTRIDGE. A 400CC BOLUS OF NORMAL SALINE WAS ADMINISTERED. THE PT REGAINED CONSCIOUSNESS FOLLOWING THE SALINE BOLUS AND REPORTED DIFFICULTY BREATHING WITH WHEEZING AND A SWOLLEN TONGUE. AN ESTIMATED 190CC BLOOD LOSS OCCURRED WHEN RINSEBACK WAS NOT COMPLETED. THE PT WAS TRANSFERRED TO A LOCAL HOSPITAL. BENADRYL WAS ADMINISTERED BY THE EMT. THE PT WAS EVALUATED AND RELEASED FROM THE ED WITH NO MEDICAL PROBLEMS FOUND. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 8057701

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other