BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF GEMSTAR W CLR

    MDR report key: 1338234 · Received March 2, 2009

    Report

    Report Number
    9615050-2009-00051
    Event Type
    Malfunction
    Date Received
    March 2, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 23, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K060806
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY THE HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE FILTER. IT WAS REPORTED THE HOMECARE PT RETURNED TO THE CLINIC AND THE TUBING SET AND SOLUTION CONTAINER WERE REPLACED AND THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF GEMSTAR W CLR 80FRN FPA HOSPIRA COSTA RICA LTD. NA 660215H

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT