BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ DRIVER ED 2

    MDR report key: 2043235 · Received February 24, 2011

    Report

    Report Number
    9615050-2011-00109
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 28, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE PUMP HISTORY WAS DOWNLOADED AT THE USER FACILITY. A REVIEW OF THE PUMP HISTORY INDICATES THAT ON (B)(6) 2011 AT 1815, LINE A WAS PROGRAMMED TO DELIVER PROPOFOL 10 MG/ML, (B)(6), WITH A DOSE OF 50 MCG/KG/MIN, WITH A VTBI OF 100 ML AND A RATE OF 29 ML/HR FOR A DURATION OF 3 HOURS, 26 MINUTES AND THE DELIVERY WAS STARTED. AT 1816, THE VOLUMES ON LINES A AND B WERE CLEARED. WITHIN THE SAME MINUTE, THE DEVICE ALARMED N250 (DOOR OPEN WHILE PUMPING). AT 1817, THE DELIVERY ON LINE A WAS RESTARTED. AT 2112, THE DEVICE ALARMED N250 (DOOR OPEN WHILE PUMPING). AT 2113, THE DEVICE WAS REPROGRAMMED WITH A VTBI OF 85 ML. AT 0008, THE DEVICE ALARMED N161 (LINE A VTBI COMPLETE). THE VOLUME ON LINE A WAS CLEARED WITH A VOLUME INFUSED OF 170.5 ML. A REVIEW OF THE DEVICE HISTORY INDICATED THE DEVICE DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. AT 2100, LINE A OF THE PUMP WAS PROGRAMMED TO DELIVER PROPOFOL 100 MG/100 ML, A DOSE OF 50 MCG/KG/MIN, AT A CALCULATED RATE OF 29 ML/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AT 2315, THE NURSE NOTED THE PROPOFOL CONTAINER WAS EMPTY. THE CUSTOMER CONTACT STATED THE DELIVERY WAS EXPECTED TO BE COMPLETE AT MIDNIGHT. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER ED 2 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PLUM A+ SOFTWARE MODULE, (B)(4)