BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM XLD 110V L.A.

    MDR report key: 4142934 · Received September 12, 2014

    Report

    Report Number
    9615050-2014-05193
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    January 1, 2014
    Report Date
    August 22, 2014
    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

    THE DEVICE WAS RECEIVED. 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

    DURING TESTING AT THE USER FACILITY, THE DEVICE DELIVERED MORE THAN EXPECTED. THE DEVICE WAS RETURNED TO THE BIOMED DEPT WITH A NOTE THAT STATED "DAMAGED." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING OR EVENTS DETAILS WERE NOT AVAILABLE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565406 PLUM XLD 110V L.A. 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK