BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTXF SYM CNVTP 2CLVE

    MDR report key: 3853422 · Received April 4, 2014

    Report

    Report Number
    9615050-2014-02530
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS CONNECTED TO A 3 WAY CONNECTOR AND BEING USED TO DELIVERY AN UNSPECIFIED CONCENTRATION OF VAMIN AT A RATE OF 40 ML/HR VIA PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S MOTHER NOTED THAT THE TUBING WAS WET. IT WAS REPORTED THAT SOLUTION LEAKED FROM A CRACK AT AN UNSPECIFIED LOCATION ON THE FILTER OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205004 LTXF SYM CNVTP 2CLVE 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED 3 WAY CONNECTOR, LIST #UNK, MFR: UNK