BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+3 PLATINUM

    MDR report key: 2033552 · Received March 24, 2011

    Report

    Report Number
    9615050-2011-00191
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 19, 2011
    Report Date
    February 23, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K024084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FOUND ON (B)(6) 2011 AT 0328, LINE B WAS PROGRAMMED TO DELIVER AT A RATE OF 500 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 2 ML, FOR A DURATION OF 0, AND THE DELIVERY WAS STARTED AND COMPLETED. AT 0421, THE DELIVERY ON LINE A WAS PROGRAMMED TO DELIVER IN THE DOSE CALCULATION MODE, WITH A CONCENTRATION ON 10 ML/ML, PT (B)(6), WITH A DOSE OF 60 MCG/KG/MIN, A VTBI OF 20 ML, AT A CALCULATED RATE OF 30.2 ML/HR, FOR A DURATION OF 39 MIN, AND THE DELIVERY ON LINE A WAS STARTED. AT 0459 THE DELIVERY WAS STOPPED AND THE PUMP WAS REPROGRAMMED TO DELIVER A VTBI OF 80 ML, FOR A DURATION OF 2 HOURS AND 38 MINUTES, AND THE DELIVERY WAS STARTED. AT 0515, THE DELIVERY ON LINE A WAS STOPPED AND THE PUMP WAS REPROGRAMMED TO DELIVER A DOSE OF 500 MCG/KG/MIN INSTEAD OF THE REPORTED 60 MCG/KG/MIN, WITH A VTBI OF 72.2 ML, AT A CALCULATED RATE OF 252 ML/HR, FOR A DURATION OF 17 MIN, AND THE DELIVERY WAS STARTED. AT 0532, THE PUMP ALARMED N161 LINE A VTBI COMPLETE. AT 0538, LINE A WAS REPROGRAMMED TO DELIVER A VTBI OF 25 ML, AT THE PREVIOUSLY CALCULATED RATE OF 252 ML/HR, AND THE DELIVERY WAS STARTED. AT 0538, THE DELIVERY WAS STOPPED AND LINE A WAS REPROGRAMMED TO DELIVER A DOSE OF 20 MCG/KG/MIN, AT A CALCULATED RATE OF 10.1 ML/HR, WITH A VTBI OF 10.5 ML, FOR A DURATION OF 1 HR AND 2 MIN, AND THE DELIVERY WAS STARTED. AT 0543, THE DELIVERY WAS STOPPED AND LINE A WAS REPROGRAMMED TO DELIVER A DOSE OF 60 MCG/KG/MIN, WITH A VTBI OF 9.7 ML, AT A CALCULATED RATE OF 30.2 ML/HR, FOR A DURATION OF 19 MINS, AND THE DELIVERY WAS STARTED. AT 0544 THE DELIVERY WAS STOPPED WITH A VOLUME INFUSED OF 156.7 ML AND THE PUMP WAS TURNED OFF. A REVIEW OF THE HISTORY FOUND THE PUMP DELIVERED AS PROGRAMMED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, CHANNEL 2 OF THE DEVICE WAS PROGRAMMED IN THE DOSE CALCULATION MODE TO DELIVER PROPOFOL 10 MG/ML WITH A DOSE OF 60 MCG/KG/MIN, (B)(6) AND THE DELIVERY WAS STARTED. NO FURTHER PARAMETERS WERE PROVIDED. AT 0600, THE NURSE WENT INTO THE PT'S ROOM TO DECREASE THE RATE AND AT THIS TIME NOTED THAT THE PROPOFOL CONTAINER WAS EMPTY. IT WAS REPORTED THAT THE PT'S BLOOD PRESSURE HAD DECREASED TO AN UNSPECIFIED LEVEL. THE PHYSICIAN WAS NOTIFIED. THE PT WAS REPORTEDLY TREATED; HOWEVER, NO SPECIFIC TREATMENT DETAILS WERE PROVIDED. THE CUSTOMER CONTACT STATED, "THERE WAS NO PERMANENT INJURY OR HARM" TO THE PT. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE DEVICE PASSED TESTING. THE CUSTOMER CONTACT INDICATED THAT THE PROPOFOL CONTAINER THAT WAS RETURNED WITH THE DEVICE TO THE BIOMEDICAL DEPARTMENT HAD APPROX 10-20 ML REMAINING. DURING A REVIEW OF THE PUMP HISTORY, IT WAS NOTED THAT THE DEVICE HAD BEEN PROGRAMMED TO DELIVER A DOSE OF 500 MCG/KG/MIN INSTEAD OF THE REPORTED DOSE OF 60 MCG/KG/MIN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 PLATINUM 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R PROPOFOL, (B)(4)