BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLD 110V L.A. REF

    MDR report key: 3040231 · Received April 3, 2013

    Report

    Report Number
    9615050-2013-00596
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE DOOR ROLLER WAS BROKEN. THE DEVICE WAS RETURNED TO THE BIOMEDICAL ENGINEERING DEPT FOR AN UNSPECIFIED REASON. NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE DEVICE DOOR ROLLER WAS BROKEN. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136856 XLD 110V L.A. REF 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK