BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA

    MDR report key: 3033405 · Received February 28, 2013

    Report

    Report Number
    3033405
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    November 11, 2012
    Report Date
    February 28, 2013
    Manufacturer
    NAVILYST MEDICAL, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    NURSES WERE ASPIRATING BLOOD SAMPLES THROUGH A VALVED PICC LUMEN. EIGHT BLOOD SAMPLES OUT OF ABOUT 100 OVER A PERIOD OF 4 MONTHS WERE HEMOLYZED.======================MANUFACTURER RESPONSE FOR PICC, XCELA (PER SITE REPORTER).======================THEY BELIEVE THAT IT IS A STAFF EDUCATION ISSUE ALTHOUGH THEY DO NOT HAVE A CURRENT "HOW TO" POSTER. THIS HAS LED TO CONFUSION ABOUT WHAT THE PROPER VALVE-OPENING TECHNIQUE SHOULD BE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BLOOD SAMPLES DRAWN FROM PICC THAT WAS ALSO USED FOR CHEMOTHERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89339 XCELA CATHETER LJS NAVILYST MEDICAL, INC * 4476057

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR NO OTHER THERAPIES