BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1932957 · Received December 13, 2010

    Report

    Report Number
    3003464075-2010-00134
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 14, 2010
    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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK OF THE PT'S BLOOD IN A TIMELY MANNER, AS INSTRUCTED IN THE USER'S GUIDE WHEN A POWER FAILURE OCCURS. FACILITY STAFF HAS BEEN NOTIFIED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A POWER FAILURE LASTING SEVERAL MINUTES OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. ONCE POWER WAS RESTORED THE CYCLER WOULD NOT ALLOW TREATMENT TO BE RESTARTED DUE TO THE ELAPSED TIME WITHOUT POWER AND THE BLOOD PUMP OFF. THE OPERATOR ENDED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. PRIOR TO THIS EVENT, THE PT'S HEMOGLOBIN WAS 6.8. FOLLOWING THE ADDITIONAL BLOOD LOSS, THE PT WAS HOSPITALIZED AND RECEIVED 2 UNITS OF BLOOD. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170-B 0067701

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other