BEUDAMED
    FDA Adverse Event Death Summary report: N

    LC PCA V 5.6

    MDR report key: 1358825 · Received April 9, 2009

    Report

    Report Number
    2921482-2009-00125
    Event Type
    Death
    Date Received
    April 9, 2009
    Date of Event
    February 28, 2009
    Report Date
    March 13, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K043256
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER, THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING RESULTING IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED TO DELIVER DILAUDID 1MG/ML, IN THE CONTINUOUS ONLY MODE, WITH A 0.8MG/HR CONTINUOUS RATE. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT STATED THAT THE DEVICE PROGRAMMING WAS CONFIRMED BY TWO NURSES TO BE CORRECT. IN 2009 AT 1533, THE PATIENT EXPIRED. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT WAS A DNR (DO NOT RESUSCITATE) STATUS AND HIS DEATH WAS "IMMINENT AND EXPECTED." NO AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT AT AN UNSPECIFIED TIME FOLLOWING THE PATIENT'S DEATH, THE NURSE NOTED THAT 19ML WAS REMAINING IN THE VIAL INSTEAD OF THE EXPECTED 28ML. THE CUSTOMER CONTACT STATED THAT IT APPEARS THAT THE CONCENTRATION "PROGRAMMING WAS INCORRECT"; HOWEVER, NO SPECIFIC DETAILS COULD BE PROVIDED. THE CUSTOMER CONTACTED INDICATED THAT THERE WAS NOT A "PROBLEM WITH THE DEVICE." THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA V 5.6 80MEA MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death DILAUDID