BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2436914 · Received January 30, 2012

    Report

    Report Number
    3003464075-2012-00007
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    December 20, 2012
    Report Date
    January 1, 2012
    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

    FACILITY STAFF ATTRIBUTED THE BLOOD LOSS EVENTS TO NEEDLE INFILTRATION AND USE ERROR. THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION OCCURRED. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS AS WELL AS INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK OF THE PATIENT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT'S BLOOD WAS NOT RETURNED DURING THREE ROUTINE HEMODIALYSIS TREATMENTS BETWEEN (B)(6) 2012 AND (B)(6) 2012, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 FOR EACH EVENT. HB DECREASED FROM 15.5 G/DL ON (B)(6) 2012 TO 7.0 G/DL ON (B)(6) 2012. THE PATIENT WAS GIVEN THREE DOSES OF EPOGEN AND RECEIVED TWO UNITS OF BLOOD ON (B)(6) 2012. 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 1107702

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other