BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 3111669 · Received May 7, 2013

    Report

    Report Number
    9615050-2013-01077
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    THE CUSTOMER CONTACT REPORTED THAT THE DEVICE BAR CODE READER DID NOT IDENTIFY THE VIAL CORRECTLY. IT WAS REPORTED THAT DURING DEMONSTRATION OF THE DEVICE DURING INSTALLATION, THE VIAL WAS LOADED INTO THE DEVICE. AT THIS TIME THE BAR CODE READER CORRECTLY IDENTIFIED THE MORPHINE VIAL AS 5 MG/ML, AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED A NEW VIAL OF MORPHINE WITH A CONCENTRATION OF 1 MG/ML WAS LOADED INTO THE DEVICE TO DEMONSTRATE THE WARNING MESSAGE THAT IS DISPLAYED IF THE REPLACEMENT VIAL HAS A DIFFERENT CONCENTRATION. AT THAT TIME THERE WAS NO WARNING MESSAGE RECEIVED AND THE BAR CODE READER IDENTIFIED THE MORPHINE CONCENTRATION AS 5 MG/ML INSTEAD OF THE EXPECTED 1 MG/ML. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197920 LC PCA HOSPIRA MEDNE 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA