BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LFAIM/APM QLC EXT

    MDR report key: 1354027 · Received February 19, 2009

    Report

    Report Number
    9615050-2009-00036
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    January 1, 2009
    Report Date
    January 28, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K923601
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE TUBING SEPARATED FROM THE SECURE LOCK. THE TUBING SET WAS REPLACED AND THERAPY WAS RESUMED. THERE WERE NOT REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LFAIM/APM QLC EXT 80FRN FPA HOSPIRA COSTA RICA LTD. NA 420505H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK