BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1974321 · Received January 21, 2011

    Report

    Report Number
    3003464075-2011-00007
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 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 REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK OF THE PT'S BLOOD DUE TO AIR VISIBLE IN THE EXTRACORPOREAL BLOOD CIRCUIT. THE CYCLER ALARMED APPROPRIATELY TO THE PRESENCE OF AIR. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    VENOUS AIR ALARMS OCCURRED DURING TWO ROUTINE HEMODIALYSIS TREATMENTS. THE FIRST TREATMENT WAS DISCONTINUED WITHOUT RINSEBACK AS THE ALARM COULD NOT BE RESOLVED. THE SECOND TREATMENT WAS ENDED WITHOUT RINSEBACK WHEN THE OPERATOR CROSS THREADED THE SYRINGE AND BROKE THE POST FILTER PORT CAP AFTER INITIALLY REMOVING AIR AND RESOLVING THE ALARM. THE PT HAD AN ESTIMATED BLOOD LOSS OF 190 CC FOR EACH TREATMENT. THE PT'S HGB LEVEL ON (B)(6) 2010 WAS 10.4 G/DL, APPROX ONE MONTH PRIOR TO THE EVENT. ON (B)(6) 2011, APPROX TWO WEEKS AFTER THE EVENT, THE PT'S HGB LEVEL WAS 8.8 G/DL. TWO DAYS LATER, THE PT'S EPOGEN WAS INCREASED FROM 10,000 UNITS 1X/WK TO 8,000 UNITS 2X/WK. 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-B 00117706

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other