BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2058371 · Received April 8, 2011

    Report

    Report Number
    3003464075-2011-00036
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 18, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED TO NXSTAGE FOR EVAL. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED WITH THIS LOT OF DIALYSATE SAKS. THE PT HAD ALREADY RECEIVED TWO DIALYSATE TREATMENTS WITH THE SAME DIALYSATE BATCH WITH NO PROBLEMS. IT IS SUSPECTED THAT THE PT'S INFECTION WAS LIKELY CAUSED BY TOUCH CONTAMINATION BY THE PT. THE USER GUIDE INCLUDES ADEQUATE WARNINGS AND INSTRUCTIONS REGARDING THE USE OF ASEPTIC TECHNIQUE WHEN MAKING SAK AND CARTRIDGE CONNECTIONS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    APPROX 1/2 WAY INTO A ROUTINE HEMODIALYSIS TREATMENT PT EXPERIENCED NAUSEA AND VOMITING, SELF-MEDICATED WITH REGLAN; THEN PT DEVELOPED A FEVER, BECAME HYPOTENSIVE AND ANSWERED QUESTIONS INAPPROPRIATELY. SALINE BOLUS OF 700CC WAS ADMINISTERED. PT WAS TRANSPORTED TO ED AND ADMITTED TO ICU WITH SEPTIC SHOCK. BLOOD CULTURES POSITIVE FOR (B)(6). PT FULLY RECOVERED AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2011. PT WAS ADMINISTERED ERTAPENEM FOR 7 DAYS IVP. NO OTHER MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. SAK-302 FG-101016-53

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| O