BEUDAMED
    FDA Adverse Event Death Summary report: N

    NXTSTAGE SYSTEM ONE

    MDR report key: 1843566 · Received September 21, 2010

    Report

    Report Number
    3003464075-2010-00088
    Event Type
    Death
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CARTRIDGE HAS NOT BEEN RETURNED FOR EVALUATION; HOWEVER, A PHOTOGRAPH WAS PROVIDED AND INDICATES THAT THE CARTRIDGE WAS MISLOADED INTO THE CYCLER BY THE OPERATOR AS THE TUBING AROUND THE FLUID AIR DETECTOR WAS PINCHED. REVIEW OF THE CYCLER DATA LOG FILE ALSO INDICATES THE ROOT CAUSE OF THE ALARMS AND CAUTIONS WAS DUE TO MISLOADING OF THE CARTRIDGE. FIELD SERVICE ENGINEER INSPECTED AND TESTED THE AIR SENSOR AND FOUND NO PROBLEMS. BOTH THE USER'S GUIDE AND ONEVIEW DISPLAY INSTRUCTIONS INCLUDE REQUIREMENT FOR THE OPERATOR TO MANUALLY LOAD THE TUBING INTO THE AIR SENSORS BEFORE CLOSING THE CYCLER DOOR. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    INTENSIVE CARE UNIT WITH POSTPARTUM CARDIOMYOPATHY WITH A BI-VAD IMPLANT AND MULTIPLE CO-MORBIDITIES WAS ON CRRT FOR MULTIPLE WEEKS. TREATMENT WAS ROUTINELY ENDED TO CHANGE TO A NEW CARTRIDGE. NURSE UNABLE TO PRIME A NEW CARTRIDGE WITH MULTIPLE FLUID AIR ALARMS DURING PRIME. A SECOND CARTRIDGE WAS ABLE TO PASS THE PRIME AND ALARMS TEST, HOWEVER, AS SOON AS TREATMENT WAS INITIATED, MULTIPLE FLUID AIR CAUTIONS OCCURRED WHICH COULD NOT BE RESOLVED AND TREATMENT WAS ENDED. DURING THE APPROXIMATELY 3 HOURS SPENT TRYING TO START UP THE TREATMENT, THE PATIENT'S POTASSIUM RAPIDLY ELEVATED FROM APPROXIMATELY 3.8 TO ABOVE 7. PATIENT CODED, WAS UNABLE TO BE RESUSCITATED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXTSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Death