BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA HOSPIRA MEDNE

    MDR report key: 2919891 · Received January 14, 2013

    Report

    Report Number
    9615050-2013-00075
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. THE DEVICE HISTORY WAS DOWNLOADED AT THE SERVICE CENTER. A REVIEW OF THE HISTORY INDICATES THAT ON (B)(4) 2012 BETWEEN 0145 AND 0150, THE DEVICE WAS POWERED ON, HISTORY CLEARED, CHECK SYRINGE ALARM, CHECK INJECTOR ALARM, MEPERIDINE 10MG/ML WAS CONFIRMED, SET ADULT CCA, THE DEVICE WAS PROGRAMMED IN THE PCA AND CONTINUOUS MODE, WITH A 10MG PCA DOSE, A 10 MIN PCA LOCKOUT, A 10MG/HR CONTINUOUS RATE, A 100MG FOUR HR LIMIT, THE SETTINGS WERE CONFIRMED, DOOR WAS OPENED ONCE AND LOCKED TWICE, INFUSER PAUSED ALARM, AND INFUSION WAS STARTED. BETWEEN 0151 AND 0154, THERE WAS ONE 10MG PT INITIATED PCA DELIVERY, 3 UNMET DEMANDS, INFUSER PAUSED ALARM, AND THE DOOR WAS OPENED. BETWEEN 0155 AND 0157, A 10.2MG TOTALS CLEARED, HISTORY CLEARED, A 0MG LOADING DOSE WAS SET 3 TIMES, 3 LOADING DOSE (LD) LOWER HARD LIMIT (LHL) ALERT 1MG, SET PCA DOSE 0MG, PCA DOSE LHL ALERT MG, THE PREVIOUS SETTINGS WERE RETAINED, SETTINGS CONFIRMED, THE DOOR WAS LOCKED AND INFUSION WAS STARTED. BETWEEN 0158 AND 0200, THERE WAS A 3.7MG PARTIAL PT INITIATED DELIVERY, 3 UNMET DEMANDS, INFUSER PAUSED ALARM, DOOR WAS OPENED, CHECK VIAL ALARM, CHECK SYRINGE ALARM, AND THE DEVICE WAS POWERED OFF. REVIEW OF THE HISTORY INDICATES DEVICE DELIVERED AS PROGRAMMED. 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 N UNREQUESTED BOLUS DOSE. AT 0200, THE DEVICE WAS PROGRAMMED TO DELIVER MEPERIDINE 10MG/ML, IN THE PCA AND CONTINUOUS MODE, AT A 10MG/HR CONTINUOUS RATE, WITH A 10MG PCA DOSE, A 10 MIN PT LOCKOUT, A 100MG 4 HR DOSE LIMIT AND THE DELIVERY WAS STARTED. AT THAT TIME, IT WAS REPORTED THE NURSE DEMONSTRATED THE USE OF PCA PENDENT TO THE PT BY ADMINISTERING A BOLUS DOSE. THE CUSTOMER CONTACT REPORTED AFTER THE ADMINISTRATION OF THE INITIAL BOLUS DOSE, THE NURSE NOTED THAT THE DEVICE DISPLAYED INCREMENTED AS THOUGH THE DEVICE WAS DELIVERING BOLUS DOSE W/O THE PT PENDENT BEING PRESSED. AT THAT TIME, THE PT PENDANT BEING PRESSED. AT THAT TIME, IT WAS REPORTED THE DELIVERY WAS STOPPED AND THE DEVICE WAS REPROGRAMMED. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE PROGRAMMING WAS VERIFIED BY A SECOND NURSE AND THE DELIVERY WAS RESTARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE REPORTED THE DEVICE DISPLAY WAS AGAIN INCREMENTING AS THOUGH THE DEVICE WAS DELIVERING A BOLUS DOSE W/O THE PT PENDANT BEING PRESSED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20937 LC PCA HOSPIRA MEDNE 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1