BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 3001712 · Received March 6, 2013

    Report

    Report Number
    3003464075-2013-00012
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 4, 2014
    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 TREATMENT LOG FILE WAS REVIEWED AND CONFIRMED THAT A CAUTION 40 WAS ACTIVATED FOLLOWING AN INTERRUPTION IN POWER TO THE CYCLER PRIOR TO THE TREATMENT MODE AND THAT THE OPERATOR RESPONDED CORRECTLY BY PRESSING THE TREATMENT KEY TO CLEAR THE CAUTION; OPERATOR ALSO MADE AN INCREASE TO THE ULTRAFILTRATION GOAL DURING THE TREATMENT. THE LOG FILE FURTHER DETERMINED THAT THE OPERATOR DELIVERED A SALINE BOLUS OF APPROX 450CC NEAR THE END OF THE LOG FILE; NO INDICATION OF AN AUTOMATED RINSE BACK. THE PT CONTINUES TO DIALYZE WITH THE DEVICE AND NO SUBSEQUENT SIMILAR REPORTS RECEIVED BY THIS PT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A PT CALLED TO REPORT THAT HE PASSED OUT DURING A TREATMENT ON (B)(6) 2013. THE PT STATED A CYCLER ERROR HAD OCCURRED IN A POWER RECOVERY; HE REPORTS CYCLER DID NOT DISPLAY A YELLOW CAUTION 40. OPERATOR REPORTS ENDING TREATMENT AND PT'S BLOOD WAS RINSED BACK. OPERATOR ADMINISTERED 600CC OF SALINE. PT RECOVERED. NO OTHER MEDICAL INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94968 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CYC-D2E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention