BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2232424 · Received August 26, 2011

    Report

    Report Number
    3003464075-2011-00093
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    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 CYCLER ALARMED APPROPRIATELY TO AIR IN THE CARTRIDGE. ATTEMPTS TO REMOVE AIR WITH A 10 CC SYRINGE WERE NOT SUCCESSFUL. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS AND FURTHER STATES TO USE A 20 CC SYRINGE FOR MANUAL AIR REMOVAL. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    A VENOUS AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. ATTEMPTS TO REMOVE AIR WITH A 10 CC SYRINGE WERE NOT SUCCESSFUL. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 220 CC. THE PT'S EPOGEN DOSING WAS INCREASED FROM 6,000 UNITS 1XWEEK TO 20,000 UNITS 1XWEEK DUE TO A DECREASE IN HGB FROM 10 G/DL PRE EVENT TO 9.7 G/DL POST EVENT. EXACT DATES NOT PROVIDED. NO OTHER MEDICAL INTERVENTION REPORTED.

    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 1047715

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other