BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3 V5.06

    MDR report key: 3213359 · Received July 2, 2013

    Report

    Report Number
    9615050-2013-01829
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 5, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT WHILE THE DEVICE WAS IN USE. AT AN UNSPECIFIED TIME, IN THE POST ANESTHESIA CARE UNIT (PACU), THE DEVICE WAS PROGRAMMED TO DELIVER UNSPECIFIED CONCENTRATION OF MORPHINE, IN THE PCA ONLY MODE, WITH A 1MG PCA DOSE, A 6 MINUTE LOCKOUT, AND A 24MG FOUR HOUR DOSE LIMIT. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE PT WAS TRANSFERRED TO ORTHOPEDIC FLOOR. AT THAT TIME, THE CUSTOMER CONTACT REPORTED THAT THE PT WAS ALERT AND ORIENTED, WITH A REPORTED PAIN LEVEL OF 8 OF 10. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE DEVICE WAS PROGRAMMED TO DELIVER A 2MG MORPHINE LOADING DOSE AND THE DELIVERY WAS STARTED. AT 1142, IT WAS REPORTED THAT THE FIRST PCA DOSE WAS ADMINISTERED. AT 1400, THE CUSTOMER CONTACT REPORTED THAT THE PT'S DAUGHTER NOTIFIED THE NURSE THE PT WAS LETHARGIC AND THE RAPID RESPONSE TEAM WAS CALLED. IT WAS REPORTED THAT AFTER THE RAPID RESPONSE TEAM ARRIVED, THE PT WAS UNRESPONSIVE WITH NO PULSE AND A CODE BLUE WAS CALLED. AT THAT TIME, CARDIOPULMONARY RESUSCITATION WAS INITIATED. IT WAS REPORTED THE PT WAS INTUBATED AND WAS TREATED WITH AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). NO SPECIFIC DETAILS WERE PROVIDED. ON (B)(6) 2013, AT AN UNSPECIFIED TIME, THE CUSTOMER CONTACT REPORTED THAT THE PT WAS EXTUBATED AND PLACED ON UNSPECIFIED VOLUME OF OXYGEN VIA NASAL CANULA. THE CUSTOMER CONTACT REPORTED THAT THE EVENT WAS NOT DUE TO THE DEVICE AND MAY HAVE BEEN DUE TO AN ADVERSE DRUG REACTION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301447 LIFECARE PCA 3 V5.06 80MEA MEA HOSPIRA COSTA RICA LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention MORPHINE, MANUFACTURER UNK