BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2836085 · Received November 8, 2012

    Report

    Report Number
    3003464075-2012-00083
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 10, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVIDENCE OF A DEVICE MALFUNCTION. CYCLER LOG FILE ANALYSIS INDICATES THAT THE CYCLER WAS PERFORMING AS INTENDED THROUGHOUT THE TREATMENT. APPROXIMATELY 3.5 HOURS INTO TREATMENT THE CYCLER APPROPRIATELY DISPLAYED A CAUTION 21 INDICATING A DECREASE IN VENOUS PRESSURE. THE USER GUIDE CONTAINS A WARNING THAT THE CYCLER MAY NOT DETECT SLOW FLUID OR BLOOD LEAKS FROM A VENOUS NEEDLE DISLODGEMENT AND THAT THE OPERATOR NEEDS TO CHECK ALL CONNECTIONS TO ENSURE THAT THEY ARE TIGHT, SECURE THE ACCESS DEVICE AND MONITOR FOR ANY LEAKS. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT IT WAS REPORTED THAT THE VENOUS NEEDLE DISLODGED FROM THE PATIENT'S ACCESS. VOLUME OF BLOOD LOSS UNKNOWN. PATIENT WAS SEEN AT CLINIC, DATE UNKNOWN, FOLLOWING THE BLOOD LOSS; NURSE CALLED 911 AND PATIENT WAS TRANSPORTED TO THE ED. HE WAS ADMITTED OVERNIGHT AND TRANSFUSED 2 UNITS OF PRBCS. PATIENTS' HB ON (B)(6) 2012 WAS 10.5 AND UPON ADMISSION HB WAS 7.2. NO OTHER MEDICAL INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-171-B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O