BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1515746 · Received October 23, 2009

    Report

    Report Number
    3003464075-2009-00320
    Event Type
    Injury
    Date Received
    October 23, 2009
    Date of Event
    September 21, 2009
    Report Date
    September 25, 2009
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. THE USER'S GUIDE CONTAINS ADEQUATE WARNINGS TO NOT USE DIALYSATE SAK IF PACKAGE IS DAMAGED, LEAKING, OR IF ANY CONNECTOR PROTECTIVE CAPS ARE LOOSE, DISCONNECTED OR MISSING. USER'S GUIDE ALSO ADVISES PATIENTS TO USE ASEPTIC TECHNIQUE TO PREVENT INFECTIONS. THERE HAVE BEEN NO OTHER SIMILAR REPORTS. THIS REPORT IS CONSIDERED CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE EVENING FOLLOWING A ROUTINE HEMODIALYSIS TREATMENT, PT COMPLAINED OF CHILLS AND FEVER, PT WAS ADMITTED TO HOSPITAL IN 2009 WITH CATHETER INFECTION. PT RECEIVED 3 DOSES OF VANCOMYCIN 1 GRAM EACH AND WAS DISCHARGED ON THE THIRD DAY. DIALYSIS NURSE ADMINISTERED A 4TH DOSE OF VANCOMYCIN 1 GM 3 DAYS LATER. IT WAS REPORTED THAT THE SHORT LINE SEGMENT WITH THE BLUE CLAMP ON THE DIALYSATE DISPOSABLE WAS LOOSE AND FELL OFF. THE OPERATOR INDICATED THAT THEY REATTACHED IT AND CONTINUED TO MAKE A BATCH OF DIALYSATE. NO CULTURES WERE DONE ON THE BATCH OF DIALYSATE WHICH WAS USED FOR THE DIALYSIS TREATMENT PRECEDING THE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-001 FG-090625-53

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization