BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3121775 · Received May 14, 2013

    Report

    Report Number
    3003464075-2013-00019
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 17, 2013
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT MALFUNCTION HAS BEEN ALLEGED. DIAGNOSTIC LOGS ARE PENDING RECEIPT FOR FURTHER INVESTIGATION. THE USER WAS DISCHARGED WITH A HOLTER CARDIAC MONITOR AFTER INPATIENT OBSERVATION COMPLETED. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED. SUBSEQUENT OUTPATIENT HEMODIALYSIS TREATMENT ON (B)(6) 2013 WAS UNEVENTFUL. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING RISKS ASSOCIATED WITH DIALYSIS THERAPY AND THE NEED TO MONITOR TO DETECT POTENTIAL COMPLICATIONS EARLY AND INITIATE APPROPRIATE REMEDIAL MEASURES IF NECESSARY.

    Description of Event or Problem · 1

    APPROXIMATELY 1.5 HOURS AFTER A HEMODIALYSIS TREATMENT INITIATED AT OUTPATIENT FACILITY CENTER, THE USER BECAME UNRESPONSIVE AFTER COMPLAINING OF NAUSEA. HEMODIALYSIS WAS DISCONTINUED AND A 200 CC NORMAL SALINE BOLUS DOSE WAS ADMINISTERED. DURING THE EVENT, THE USER'S "HEART RATE DROPPED FROM 42 TO 64 BEATS PER MINUTE." THE USER'S BLOOD PRESSURE REMAINED UNCHANGED. A DEEP STERNAL RUB AROUSED THE USER. THE USER WAS TRANSFERRED TO AN INPATIENT FACILITY FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212474 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170C 2117746

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization