BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 716418 · Received May 17, 2006

    Report

    Report Number
    3003464075-2006-00064
    Event Type
    Injury
    Date Received
    May 17, 2006
    Date of Event
    April 17, 2006
    Report Date
    April 17, 2006
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SHORTLY AFTER ROUTINE HEMODIALYSIS TREATMENT STARTED, PATIENT COMPLAINED OF A METALLIC TASTE AND NUMBNESS IN FACE. PATIENT THEN BEGAN TO LOSE LUCIDITY, PASSED OUT AND WENT INTO SEIZURE. NURSE ADMINISTERED 400CC SALINE BOLUS AND PATIENT RECOVERED. OXYGEN WAS ALSO ADMINISTERED TO PATIENT. TREATMENT DISCONTINUED. NURSE REPORTED THAT PATIENT ALSO HAD SIMILAR SYMPTOMS AT BEGINNING OF PREVIOUS TREATMENT 04/2006. PATIENT SYMPTOMS IN 04/2006 SUBSIDED AFTER APPROXIMATELY 3 MINUTES WITHOUT INTERVENTION AND TREATMENT COMPLETED WITHOUT FURTHER INCIDENT. PATIENT HAD JUST STARTED DIALYSIS WITH NXSTAGE SYSTEM ONE AND HAD COMPLETED FOUR PRIOR TREATMENTS WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-160 6027702AX/5107703

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other