BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1163136 · Received September 16, 2008

    Report

    Report Number
    3003464075-2008-00431
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. REVIEW OF THE CYCLER LOG FILES INDICATE THAT MULTIPLE VENOUS AIR ALARMS OCCURRED THAT NOT RESPONDED APPROPRIATELY TO BY THE OPERATOR. THERE IS NO EVIDENCE THAT THE OPERATOR ATTEMPTED TO FOLLOW AIR REMOVAL PROCEDURES IN ACCORDANCE WITH USER'S GUIDE INSTRUCTIONS. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS. AIR ALARMS AT THE VERY BEGINNING OF THE TREATMENT ARE TYPICALLY INDICATIVE OF INADEQUATE AIR REMOVAL BY THE OPERATOR DURING PRIMING OF THE CARTRIDGE. THE CYCLER ALARMED APPROPRIATELY. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. MULTIPLE VENOUS AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT THAT COULD NOT BE RESOLVED BY THE OPERATOR. THE PATIENT REPORTED CHEST PAIN AND A DROP IN BP (ACTUAL VALUE NOT REPORTED). TREATMENT WAS ENDED WITHOUT PERFORMING RINSEBACK RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT WAS TRANSFERRED TO THE ER AND RELEASED POST OBSERVATION. PHYSICIAN SPECULATED THAT THE PATIENT RECEIVED AN INFUSION OF AIR BUT NO DIAGNOSTIC TESTS WERE PERFORMED TO CONFIRM. NO 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other