BEUDAMED
    FDA Adverse Event Other Summary report: N

    APM II SYS KIT USED

    MDR report key: 1624636 · Received March 5, 2010

    Report

    Report Number
    2921482-2010-00114
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    January 30, 2010
    Report Date
    February 4, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    PMA / PMN Number
    K953731
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE PUMP HISTORY WAS DOWNLOADED AT THE MANUFACTURING FACILITY. A REVIEW OF THE PUMP HISTORY FOUND THAT ON THE REPORTED EVENT DATE OF (B)(6) 2010, THE PUMP WAS NOT POWERED ON; THEREFORE, THE HISTORY CANNOT BE UTILIZED TO EVALUATE THE REPORTED EVENT. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED OPERATOR ERROR, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF DEMEROL, IN THE PCA CONTINUOUS MODE. SPECIFIC PUMP PROGRAMMING PARAMETERS WERE NOT PROVIDED; HOWEVER, THE CUSTOMER CONTACT REPORTED THE PATIENT WAS TO RECEIVE 60MG EVERY 4 HOURS. IT WAS REPORTED THAT ON (B)(6) 2010 AT SHIFT CHANGE, THE PATIENT WAS FOUND EXPIRED. THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED 600MG EVERY 4 HOURS INSTEAD OF THE INTENDED 60MG EVERY 4 HOURS. THE CUSTOMER CONTACT REPORTED THE EVENT WAS "AN INTERNAL THING" AND RELATED TO "A USER ERROR." THOUGH REQUESTED, THE CUSTOMER CONTACT STATED NO FURTHER SPECIFIC EVENT INFORMATION WOULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APM II SYS KIT USED 80FRN MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DEMEROL: MANUFACTURED BY BAXTER