BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LC PCA REFURB 802.11

    MDR report key: 2854542 · Received November 29, 2012

    Report

    Report Number
    9615050-2012-01436
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 4, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    MEA
    PMA / PMN Number
    K042800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED IN THE PCA+CONTINUOUS MODE, TO DELIVER DILAUDID 30MG/ML, AT A CONTINUOUS RATE OF 0.3MG/HR, WITH A 0.3MG PCA DOSE, AN 8 MINUTE PATIENT LOCKOUT, A 9MG FOUR HOUR DOSE LIMIT, AND THE DELIVERY WAS STARTED. ON (B)(6) 2012 AT 0900, IT WAS REPORTED THAT A NEW 30ML VIAL WAS LOADED INTO THE DEVICE AND THE DELIVERY WAS RESTARTED. THE CUSTOMER CONTACT REPORTED THAT EVERY FOUR HOURS, TWO NURSES CHECKED THE PROGRAMMING AND CLEARED THE SHIFT TOTALS. AT 0130, IT WAS REPORTED THAT THE 6.1ML SHIFT TOTAL WAS CLEARED, AT 1545, IT WAS REPORTED THAT THE DEVICE ALARMED FOR EMPTY SYRINGE; HOWEVER, THE DISPLAY INDICATED 2ML HAD BEEN DELIVERED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC PCA REFURB 802.11 80MEA MEA HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR