BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1780804 · Received July 27, 2010

    Report

    Report Number
    3003464075-2010-00068
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE EVENT IS ATTRIBUTED TO INCORRECT CONNECTIONS MADE FOR RINSEBACK BY THE OPERATOR. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR MAKING PT CONNECTIONS FOR TREATMENT AND RINSEBACK. FACILITY STAFF HAS PROVIDED ADD'L TRAINING. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    ARTERIAL AIR ALARMS OCCURRED WHEN STARTING RINSEBACK DURING A ROUTINE HEMODIALYSIS TREATMENT BECAUSE THE OPERATOR DISCONNECTED THE ARTERIAL LINE FROM THE PT BUT DID NOT CONNECT THE LINE TO THE SALINE BAG BEFORE STARTING RINSEBACK. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. THE PT WAS STARTED ON EPOGEN DUE TO A DECREASE IN HEMOGLOBIN LEVEL AFTER THE EVENT. NO ADD'L 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-B 0037712

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other