BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2421476 · Received January 12, 2012

    Report

    Report Number
    3003464075-2012-00002
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    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 ALARM IS ATTRIBUTED TO THE OPERATOR NOT CLAMPING THE SALINE LINE AS DIRECTED. THE BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT COMPLETING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    A VENOUS AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, DUE TO THE OPERATOR NOT CLAMPING THE SALINE LINES AS DIRECTED IN THE USER'S GUIDE WHICH INTRODUCED AIR INTO THE EXTRACORPOREAL CIRCUIT. THE OPERATOR DISCONTINUED TREATMENT W/O PERFORMING RINSEBACK DUE TO THE AMOUNT OF TIME ELAPSED, RESULTING IN A BLOOD LOSS OF 190CC. HB DECREASED FROM 9.6 G/DL ON (B)(6) 2011 TO 8.9 G/DL ON (B)(6) 2011, (7 DAYS POST BLOOD LOSS). EPOGEN WAS INCREASED FROM 20,000 UNITS 1XWEEK TO 2XWEEK ON (B)(6) 2011 (11 DAYS POST BLOOD LOSS). NO FURTHER 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 1117705

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other