BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXSTAGE

    MDR report key: 1855106 · Received September 27, 2010

    Report

    Report Number
    1855106
    Event Type
    Death
    Date Received
    September 27, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    NXSTAGE MEDICAL INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT 1003, NXSTAGE (CRRT) MACHINE ALARM NOTING "CHANGE CARTRIDGE: CARTRIDGE LIFE EXCEEDED." AT 1023, RN BEGAN CHANGING CARTRIDGE. DURING PRIMING, RN RECEIVED NXSTAGE ALARM "CHECK FLUID LINE INLET: AIR DETECTED IN FLUID LINE INLET" AND WAS NOT ABLE TO PROCEED WITH TREATMENT. NXSTAGE'S TROUBLESHOOTING INSTRUCTIONS ON THE MACHINE WERE FOLLOWED WITHOUT RESOLUTION OF THE VARIOUS ALARMS. TWO CALLS WERE MADE TO THE NXSTAGE TECHNICAL SUPPORT DESK. NEITHER THE MACHINE NOR VERBAL TECHNICAL SUPPORT INSTRUCTIONS INDICATED THAT A POSSIBLE MISLOAD HAD OCCURRED. DUE TO THE SOLID WHITE BACKGROUND AND CLEAR TUBING, RN COULD NOT SEE THAT THE TUBING WAS NOT LOADED CORRECTLY. RN ATTEMPTED TO PRIME A NEW CARTRIDGE, BUT RECEIVED THE SAME "CHECK FLUID LINE INLET: AIR DETECTED IN FLUID LINE INLET" MESSAGE. RN OBTAINED A SECOND MACHINE AND BEGAN PRIMING A NEW CARTRIDGE. PT BEGAN HAVING RESPIRATORY DISTRESS AT 1530, AND CONDITION DETERIORATED RAPIDLY. PT'S RIGHT SIDED HEART FAILURE WORSENED, FOLLOWED BY HYPOTENSION AND MULTIPLE ARRHYTHMIAS. CODE CALLED AT 1540. PT UNABLE TO BE RESUSCITATED AND EXPIRED AT 1635. EVAL OF MACHINE REVEALED POSSIBLE CARTRIDGE MISLOAD, CAUSING A CRACKED AIR SENSOR ON THE CRRT MACHINE, RESULTING IN MULTIPLE ALARMS AND INABILITY TO PROCEED WITH PRIMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE CRRT (CVVHD) MACHINE KDI NXSTAGE MEDICAL INC. NX1000-2 0067807 (CARTRIDGE)

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death| L