BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ PUMP

    MDR report key: 1032796 · Received April 23, 2008

    Report

    Report Number
    2921482-2008-00134
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 26, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K052052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE DEVICE HISTORY WAS DOWNLOADED AND PRINTED AT THE MANUFACTURING FACILITY. A REVIEW OF THE DEVICE HISTORY INDICATES THAT IN 2008 AT 2150, LINE A OF THE DEVICE WAS PROGRAMMED IN THE ML/HR MODE TO DELIVER AT A RATE OF 120 ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 480 ML FOR A DURATION OF 4 HOURS AND THE DELIVERY WAS STARTED. AT 2325, THE DELIVERY WAS STOPPED. AT 2326, THE DELIVERY ON LINE A WAS RESUMED. AT 2327, THE DELIVERY IN LINE A WAS STOPPED AND WITHIN THE SAME MINUTE LINE A WAS REPROGRAMMED IN THE ML/HR MODE TO DELIVER AT A RAGE OF 12 ML/HR WITH A VTBI OF 24ML FOR A DURATION OF 2 HOURS AND THE DELIVERY WAS STARTED. AT 2344, THE DEVICE WAS POWERED OFF. REVIEW OF THE DEVICE HISTORY INDICATES THAT THE DEVICE DELIVERED AS PROGRAMMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE PUMP WAS PROGRAMMED TO DELIVER TOTAL PARENTERAL NUTRITION (TPN) AT A RATE OF 12ML/HR WITH AN UNSPECIFIED VTBI (VOLUME TO BE INFUSED) AND THE DELIVERY WAS STARTED. APPROXIMATELY ONE HOUR LATER, THE NURSE NOTED THE PATIENT WAS TACHYCARDIC AND HYPERTENSIVE. AT THAT TIME, THE NURSE NOTED THE PUMP WAS DELIVERING AT A RATE OF 120ML/HR INSTEAD OF THE INTENDED RATE OF 12 ML/HR. THE PHYSICIAN WAS NOTIFIED AND THE DELIVERY WAS STOPPED. IT WAS REPORTED THAT BLOOD SAMPLES WAS DRAWN AND THE PATIENT'S SERUM GLUCOSE LEVEL WAS 435MG/DL. AT 2330 USING AN UNSPECIFIED PUMP, THE PATIENT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF INSULIN AT A DOSE OF 1UNIT/KG/HR. IN 2008 AT 1600, THE PATIENT'S SERUM GLUCOSE LEVEL WAS 73 MG/DL AND SERUM POTASSIUM LEVEL WAS 2.2 MEQ/ML. AT THIS TIME THE PATIENT WAS TREATED WITH AN UNSPECIFIED AMOUNT OF 10% DEXTROSE AND 1MEQ/KG OF POTASSIUM CHLORIDE AND THE TPN THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 1/2 Life Threatening| R TOTAL PARENTERAL NUTRITION BASE SOLUTION| LIST# 12097| PLUM A+ SOFTWARE MODULE| MANUFACTURED BY BAXTER HEALTHCARE