BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE SET

    MDR report key: 2101937 · Received May 17, 2011

    Report

    Report Number
    9616066-2011-00258
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 05/17/2011. (B)(4). USED SET WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING CONFIRMED LEAKING FROM THE PRESSURE SENSING DISC ALONG THE EDGE OF THE FILM ON THE DISC. ROOT CAUSE IDENTIFIED AS A MFG ISSUE DUE TO INCONSISTENT WELD ALONG THE CIRCULAR EDGE OF THE PRESSURE SENSING DISC.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DISC OF THE IV SET LEAKED AS SOON AS MEDICATION WAS FLUSHED THROUGH IT IN THE NICU. NO REPORT OF PT HARM. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYRINGE MODULE SET FPA CAREFUSION CORPORATION 10014914 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 10 ML BD SYRINGE| NON ALARIS ADAPTOR CONNECTED TO FEMALE LUER