BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2880824 · Received November 14, 2012

    Report

    Report Number
    2880824
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    THERE WERE MULTIPLE ATTEMPTS TO CORRECT THE PROBLEM. THE WINDOW (SCREEN) "CRASHED" ALARM CODE 600, AND KEPT GETTING A REPAIR WITH CD ROM MESSAGE. RN CALLED NXSTAGE SUPPORT WITH MULTIPLE ATTEMPTS MADE TO CORRECT THE PROBLEM. WE THEN CALLED BIOMED. THEY WERE ON THEIR WAY IN. NOTIFIED PERSONNEL TO BORROW CONTINOUS RENAL REPLACEMENT THERAPY (CRRT) MACHINE. CNS CALLED NEPHROLOGIST TO NOTIFY HIM THIS WOULD CAUSE INTERRUPTION IN HIS CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEMODIALYSIS, CONTINUOUS RENAL REPLACEMENT KDI NXSTAGE MEDICAL, INC. CEO11182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *