BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2809524 · Received October 19, 2012

    Report

    Report Number
    3003464075-2012-00075
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 22, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K111174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. A DIALYSATE SAMPLE WAS BROUGHT TO ED BUT PHYSICIAN DETERMINED TESTING NOT REQUIRED. BLOOD CULTURES WERE NEGATIVE. NO OTHER SIMILAR COMPLAINTS REPORTED FOR THIS LOT OF DIALYSATE SAKS. THIS REPORT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ABOUT 1.5 HOURS AFTER THE START OF A ROUTINE HEMODIALYSIS TREATMENT THE PATIENT COMPLAINED OF UNCONTROLLABLE SHAKING, CHILLS, AND A TEMPERATURE OF 100F. OPERATOR ENDED THE TREATMENT AND RINSED BACK THE BLOOD. PATIENT SYMPTOMS RESOLVED AFTER TREATMENT WAS DISCONTINUED. PATIENT WENT TO ED AND BLOOD CULTURES WERE DRAWN. NURSE REPORTS PATIENT REFUSED ED DISCHARGE AND WAS ADMITTED OVERNIGHT PENDING RESULTS OF BLOOD CULTURES. VANCOMYCIN 1GM ADMINISTERED. NO OTHER MEDICAL INTERVENTION PROVIDED. BLOOD CULTURES RESULTS WERE NEGATIVE.

    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 2067919

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O