BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1203000 · Received October 17, 2008

    Report

    Report Number
    3003464075-2008-00501
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. REVIEW OF THE PT'S TREATMENT DATA LOG FILES INDICATE THAT WHILE THE TREATMENT WAS IN PROGRESS, THE OPERATOR INCREASED THE TARGET WEIGHT TO REMOVE BELOW THE PT'S ESTIMATED DRY WEIGHT, RESULTING IN EXCESS FLUID REMOVAL. FACILITY STAFF WILL PROVIDE ADD'L TRAINING TO THE OPERATOR AND PT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    JUST PRIOR TO THE END OF A ROUTINE HEMODIALYSIS TREATMENT, THE PT EXPERIENCED A HYPOTENSIVE EPISODE WITH MILD TREMORS. A 600CC NORMAL SALINE BOLUS WAS ADMINISTERED TO THE PT AND TREATMENT WAS ENDED. THE PT'S SYMPTOMS RESOLVED AND 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 8077701

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention