BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA PLS II

    MDR report key: 1575055 · Received January 8, 2010

    Report

    Report Number
    2921482-2010-00008
    Event Type
    Injury
    Date Received
    January 8, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 17, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K912928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE PT EVENT WHILE THE DEVICE WAS IN USE. IN 2009 AT 0900, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DILAUDID WITH AN EIGHT MINUTE PT LOCKOUT. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. THE PT WAS BEING TREATED ON THE SURGICAL UNIT FOR AN UNSPECIFIED TRAUMA. THE CUSTOMER CONTACT REPORTED, "IN THE EARLY HOURS OF THE FOLLOWING MORNING," A CODE WAS CALLED; HOWEVER, THE CUSTOMER DECLINED TO PROVIDE SPECIFIC EVENT DETAILS. THE PT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF NARCAN AND OXYGEN THERAPY WAS INITIATED. AT AN UNSPECIFIED TIME, THE PT EXPIRED. THE CUSTOMER CONTACT INDICATED THAT AN AUTOPSY WAS PERFORMED; HOWEVER, DECLINED TO PROVIDE AUTOPSY RESULTS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT STATED THIS WAS A "NEGATIVE PT EVENT. A SENTINEL EVENT" AND THEY "DON'T BELIEVE THE EQUIPMENT WAS AT FAULT HERE." THE CUSTOMER CONTACT STATED THAT THEY "BELIEVE POSSIBLY FAMILY MEMBERS WERE INVOLVED IN PUSHING THE PT PENDANT." THOUGH REQUESTED, THE CUSTOMER CONTACT DECLINED TO PROVIDE ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLS II 80FRN MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R DILAUDID, MFR UNK