BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2010636 · Received February 24, 2011

    Report

    Report Number
    3003464075-2011-00019
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 30, 2011
    Report Date
    January 30, 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 NEEDLE DISLODGEMENT IS ATTRIBUTED TO PT MOVEMENT AND NOT TAPING NEEDLES AS REQUIRED. THE PT'S STANDARD EPOGEN DOSE WAS INCREASED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. FACILITY STAFF PROVIDED ADD'L REVIEW REGARDING SECURING THE ACCESS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN EFFLUENT PRESSURE LOW ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. WHILE ATTEMPTING TO RESOLVE THE ALARM THE PT MOVED CAUSING BOTH NEEDLES TO DISLODGE FROM THE ACCESS. TAPE HAD NOT BEEN USED TO SECURE THE NEEDLES AS REQUIRED. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. THE PT'S STANDARD EPOGEN DOSE WAS INCREASED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other