BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2436943 · Received January 30, 2012

    Report

    Report Number
    3003464075-2012-00008
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 1, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED EVENT IS ATTRIBUTED TO THE OPERATOR NOT FOLLOWING INSTRUCTIONS PER THE USER'S GUIDE. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS AS WELL AS INSTRUCTIONS FOR PERFORMING MANUAL RINSE BACK OF THE PATIENT'S BLOOD WHEN TRAINED AND INSTRUCTED BY THE FACILITY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A PRESSURE OFFSET REZEROING FAILURE ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED TREATMENT WITHOUT PERFORMING RINSEBACK OF THE PATIENT'S BLOOD, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. HB DECREASED FROM 10.7 G/DL PRE-EVENT TO 8.7 G/DL POST EVENT. THE PATIENT RECEIVED A ONE TIME DOSE OF EPOGEN POST EVENT (ACTUAL DOSAGE AND DATES NOT PROVIDED). NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170-B 1097716

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other