BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2413545 · Received January 6, 2012

    Report

    Report Number
    3003464075-2012-00001
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 9, 2011
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION IS POSSIBLE WITHOUT THE RETURNED PRODUCT; THEREFORE THE EXACT CAUSE OF THE BROKEN LUER TIP CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION OR DEFECT GIVEN THAT THE LUER CONNECTOR WAS ABLE TO BE DISCONNECTED FROM THE CARTRIDGE PRIMING SPIKE PRIOR TO MAKING THE CONNECTION TO THE PATIENT CATHETER. REQUESTS FOR ADDITIONAL INFORMATION WERE NOT RESPONDED TO. STANDARD INDUSTRY LUER COMPONENTS ARE USED IN THE CARTRIDGE ASSEMBLY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A CRRT TREATMENT THE CLINICIAN ATTEMPTED TO PAUSE TREATMENT AND SWITCH THE PATIENT BLOOD LINES, THE MALE LEUR TIP OF THE VENOUS BLOOD LINE BROKE OFF IN THE PATIENT'S ACCESS WHEN DISCONNECTING THE CARTRIDGE LINE FROM THE ACCESS. THE CATHETER HAD TO BE REPLACED BEFORE TREATMENT COULD BE CONTINUED. NO OTHER NEED FOR MEDICAL INTERVENTION WAS REPORTED. PATIENT IDENTIFIER INFORMATION WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-500 1097818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention