BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC4200 PCA PLUS AUST

    MDR report key: 2491134 · Received March 8, 2012

    Report

    Report Number
    9615050-2012-00225
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    January 1, 2011
    Report Date
    August 17, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED ON (B)(6) 2011. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME 80FRN AND HAS A 510K OF K912928. 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 DID NOT DELIVER A DOSE WHEN THE PT PENDANT WAS PRESSED. ON AN UNSPECIFIED DATE, THE DEVICE WAS RETURNED TO AN UNSPECIFIED DEPARTMENT WITH A NOTE THAT STATED, "PLUNGER MECHANISM NOT WORKING, WHEN SYRINGE IS LOADED AND PROGRAMMED, SYRINGE REMAINS ON 30MLS DESPITE PCA BUTTON BEING USED." NO SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC4200 PCA PLUS AUST UNK FPA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK