BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOSPIRA

    MDR report key: 966570 · Received January 3, 2007

    Report

    Report Number
    MW4004254
    Event Type
    Other
    Date Received
    January 3, 2007
    Date of Event
    December 13, 2006
    Report Date
    December 14, 2006
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S FAMILY REPORTS THAT THE PUMP IS NOT DELIVERING ALL OF THE TPN SOLUTION. HOSPIRA GEM STAR PUMP IS PROGRAMMED TO GIVE 3500 CC TPN/LIPIDS OVER 14 HRS WITH A 1 HR UP TIME AND 1 HR DOWN TIME. THE PUMP ALARMS THAT INFUSION IS COMPLETE AND THERE IS A VOLUME LEFT IN THE TPN/LIPID BAG OF 500 ML. THE PUMP'S END VOLUME IS READING 3500 ML. BATTERIES HAVE BEEN CHANGED TWICE, ONCE AT THE BEGINNING OF THE INFUSION AND THEN APPROX 4 HRS LATER SO THAT THE PUMP WILL RUN ALL NIGHT. THIS PROBLEM HAS HAPPENED REPEATEDLY FOR THE LAST 2 WEEKS. HOSPIRA TECHNICAL SUPPORT CONTACTED ON 12-11-2006. TECH RECOMMENDED THAT NEW PUMPS BE PROGRAMMED AND SENT TO PT AND CURRENT PUMPS BE RETURNED TO BE TESTED. THE TWO NEW PUMPS THAT WERE SENT HAVE REPEATED THE ABOVE PROBLEM WITH 500 CC OF TPN/LIPIDS LEFT AFTER PUMP ALARMS INFUSION COMPLETE WITH TOTAL VOLUME INFUSED 3500 ML. PT HAS BECOME HYPOGLYCEMIC AT THE END OF INFUSION. BLOOD GLUCOSE REPORTED ON THREE DAYS LATER WAS 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPIRA GEM STAR FRN HOSPIRA, INC. GEMSTAR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other