BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 2919769 · Received January 14, 2013

    Report

    Report Number
    9615050-2013-00076
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 2, 2012
    Report Date
    December 17, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT SERVICE CENTER. A REVIEW OF HISTORY INDICATES ON (B)(4) 2012 BETWEEN 0205 AND 0210, THE DEVICE WAS POWERED ON, HISTORY CLEARED, THERE WAS A CHECK SYRINGE AND CHECK INJECTOR ALARM, SET ADULT CCA, MEPERIDINE 10 MG/ML CONFIRMED, THE DEVICE WAS PROGRAMMED IN THE PCA + CONTINUOUS MODE, WITH A 10 MG PCA DOSE, A 10 MINUTE PCA LOCKOUT, A 10 MG/HOUR CONTINUOUS RATE, A 100 MG FOUR HOUR LIMIT, THE SETTINGS WERE CONFIRMED, DOOR WAS LOCKED, INFUSION STARTED, A 3.1 MG PARTIAL PT INITIATED DELIVERY, INFUSER PAUSED ALARM AND THE DOOR WAS OPENED. BETWEEN 0211 AND 0215, THERE WERE TWO 0 MG LOADING SET, TWO LOADING DOSE (LD) LOWER HARD LIMIT (LHL) ALERT 1 MG, DOOR WAS OPENED TWICE, LOCKED THREE TIMES, INFUSION WAS STARTED, AND 11 UNMET DEM'S. BETWEEN 0244 AND 0253 THERE WAS ONE 10 MG PT INITIATED DELIVERY, INFUSER PAUSED ALARM, CHECK VIAL ALARM, CHECK SYRINGE ALARM, 3 CHECK SETTINGS ALARM, DOOR WAS OPENED FOUR TIMES AND LOCKED THREE TIMES, AND THE DEVICE WAS POWERED OFF. REVIEW OF THE HISTORY INDICATES DEVICE DELIVERED AS PROGRAMMED. 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 UNREQUESTED BOLUS DOSE. AT 0200, THE DEVICE WAS PROGRAMMED TO DELIVER MEPERIDINE 10 MG/DL, IN THE PCA + CONTINUOUS MODE, AT A 10 MG/HR CONTINUOUS RATE, WITH A 10 MG PCA DOSE, A 10 MINUTE PT LOCKOUT, A 100 MG 4 HOUR DOSE LIMIT AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT PT'S HUSBAND NOTED THAT THE DEVICE DISPLAY WAS INCREMENTING AS THOUGH THE DEVICE WAS DELIVERING A BOLUS DOSE WITHOUT THE PT PENDANT BEING PRESSED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED THE THERAPY WAS CHANGED TO AN UNSPECIFIED MEDICATION IV PUSH. THE CUSTOMER CONTACT INDICATED THAT AT AN UNSPECIFIED TIME AFTER THE PCA THERAPY WAS DISCONTINUE, THE PT'S PAIN LEVEL WAS REPORTED AS 6 OUT OF 10. THE CUSTOMER CONTACT REPORTED THAT THE PT WAS TREATED WITH AN UNSPECIFIED MEDICATION IV PUSH. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE PT'S PAIN LEVEL DECREASED TO 3 OF 10. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21018 LC PCA HOSPIRA MEDNE 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention