BEUDAMED
    FDA Adverse Event Other Summary report: N

    NSTAGE SYSTEM ONE

    MDR report key: 614361 · Received March 30, 2004

    Report

    Report Number
    3003464075-2004-00001
    Event Type
    Other
    Date Received
    March 30, 2004
    Date of Event
    March 2, 2004
    Report Date
    March 2, 2004
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE IN-CLINIC HEMODIALYSIS TREATMENT, A PATIENT BLOOD LOSS OF APPROXIMATELY 215CC OCCURRED. THIS EVENT WAS NOT ASSOCIATED WITH A DEVICE MALFUNCTION OR SERIOUS INJURY AND IS BEING REPORTED SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS PPOLICY. NXSTAGE CLINICAL SPECIALIST WAS AT THE CLINIC AT THE TIME OF THE EVENT. STAFF NURSE INDICATED THAT SHE HAD HUNG A NEW BAG OF SALINE NEARING THE END OF TREATMENT, DURING WHICH AIR WAS INTRODUCED INTO THE BLOOD CIRCUIT. THE SYSTEM ALARMED APPROPRIATELY IN RESPONSE TO THE PRESENCE OF AIR. TROUBLESHOOTING ATTEMPTS TO MANUALLY REMOVE THE AIR WERE UNSUCCESSFUL DUE TO THE LARGE AMOUNT OF AIR IN THE DISPOSABLE CIRCUIT. TREATMENT WAS TERMINATED AND THE DISPOSABLE CARTRIDGE/FILTER WERE DISCARDED. BLOOD LOSS ESTIMATED AT APPROXIMATELY 215CC. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-153 PG-040210-01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR