BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2496327 · Received March 16, 2012

    Report

    Report Number
    3003464075-2012-00014
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    February 19, 2012
    Report Date
    February 19, 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 PROBLEM FOUND WITH RETURNED CARTRIDGE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY TO AIR IN THE EXTRACORPOREAL CIRCUIT. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT OPERATOR WAS UNABLE TO RESOLVE ALARMS; DUE TO AMOUNT OF TIME TROUBLESHOOTING BLOOD WAS NOT RINSED BACK. ESTIMATED BLOOD LOSS WAS 190CC. PATIENT'S HB ON (B)(6) 2012 WAS 9.9 AND HB ON (B)(6) 2012 WAS 9.4. EPOGEN WAS INCREASED TO 10,000 UNITS 3X/WEEK FROM 8000 UNITS 3X/WEEK. 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-170-B 1127734

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other