BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC4200 PCA PLUS AUST

    MDR report key: 2476481 · Received March 1, 2012

    Report

    Report Number
    9615050-2012-00184
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 31, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 OF 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. AT AN UNSPECIFIED TIME IN THE RECOVERY ROOM, THE DEVICE WAS PROGRAMMED TO DELIVER FENTANYL 10MCG/ML WITH A 20MCG LOADING DOSE AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT DURING AN UNSPECIFIED LENGTH OF TIME, THE DEVICE WAS REPROGRAMMED TO DELIVER TWELVE ADDITIONAL 20MCG LOADING DOSES. AT AN UNSPECIFIED TIME, THE PT COMPLAINED OF NO PAIN RELIEF. AT THIS TIME, THE NURSE NOTED THE DEVICE DISPLAY INDICATED THAT 260MCG HAD BEEN DELIVERED; HOWEVER, THE VIAL "WAS STILL FULL AT 30ML." IT WAS REPORTED THE PT'S PAIN LEVEL WAS "9/10." AT 2245, THE ANESTHETIST WAS NOTIFIED. THE PT WAS TREATED WITH 300MCG OF FENTANYL IV. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention