Events

Recall of Device Recall Plum A3 Infusion Pump System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0206-2014
  • Event Initiated Date
    2012-02-05
  • Event Date Posted
    2013-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122497
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    Hospira has received reports of distal pressure sensor calibration drift on plum a+ infusers. the following error codes may be displayed during setup or infusion signifying possible calibration drift: e180/n180, e181/n181, e186/n186, e187/n187 or e346. additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion alarms or distal occlusions that may not.
  • Action
    Hospira sent an URGENT DEVICE FIELD CORRECTION letter dated February 5, 2013 was sent to all direct accounts notifying them of the issue. For device users who experience these issues, Hospira recommends the following actions be taken: 1) Remove the pump from service and perform a Performance Verification Test (PVT) Distal Occlusion Test to determine if the distal pressure sensor is performing correctly. 2) If the device does not pass the PVT, it may indicate that the distal pressure sensor has drifted. Perform the appropraite troubleshooting and repair activities defined by the user's facility, whihc may include returning the device to Hospira for further diagnosis and servicing. The remediation for this issue is to perform a recalibration of the distal pressure sensor. Hospira also intends to release in 2013 a recommendation of a yearly test to determine if the distal pressure sensor's calibration has drifted. Customers who suspect that their device(s) may be affected by this issue are urged to contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) to report the issue. Hospira will provide loaner devices if necessary. Customers are requested to complete and return the reply form included with the notification letter per the instructions on the reply form. For questions regarding this recall call 224-212-2000.

Device

Device Recall Plum A3 Infusion Pump System
  • Model / Serial
    List No. 12348; Serial Numbers:  13740156 , 13740256 , 13740266 , 13740351 , 13740380 , 13740451 , 13740508 , 13740612 , 13740632 , 13740731 , 13740732 , 13740733 , 13740734 , 13740735 , 13740736 , 13740737 , 13740738 , 13740739 , 13740740 , 13740741 , 13740742 , 13740743 , 13740744 , 13740745 , 13740746 , 13740747 , 13740748 , 13740749 , 13740750 , 13740751 , 13740752 , 13740753 , 13740754 , 13740755 , 13740756 , 13740757 , 13740758 , 13740759 , 13740760 , 13740761 , 13740762 , 13740763 , 13740764 , 13740765 , 13740766 , 13740767 , 13740768 , 13740769 , 13740770 , 13740771 , 13740772 , 13740773 , 13740774 , 13740775 , 13740776 , 13740777 , 13740778 , 13740779 , 13740780 , 13740781 , 13740782 , 13740783 , 13740784 , 13740785 , 13740786 , 13740787 , 13740788 , 13740789 , 13740790 , 13740791 , 13740792 , 13740793 , 13740794 , 13740795 , 13740796 , 13740797 , 13740798 , 13740799 , 13740800 , 13740801 , 13740802 , 13740803 , 13740804 , 13740805 , 13740806 , 13740807 , 13740808 , 13740809 , 13740810 , 13740811 , 13740812 , 13740813 , 13740814 , 13740815 , 13740816 , 13740818 , 13740819 , 13740820 , 13740821 , 13740822 , 13740823 , 13740824 , 13740825 , 13740826 , 13740827 , 13740828 , 13740829 , 13740830 , 13740831 , 13740832 , 13740833 , 13740834 , 13740835 , 13740836 , 13740837 , 13740838 , 13740839 , 13740840 , 13740841 , 13740842 , 13740843 , 13740844 , 13740845 , 13740846 , 13740847 , 13740848 , 13740849 , 13740850 , 13740851 , 13740852 , 13740853 , 13740854 , 13740855 , 13740856 , 13740857 , 13740858 , 13740859 , 13740860 , 13740861 , 13740862 , 13740863 , 13740864 , 13740865 , 13740866 , 13740867 , 13740868 , 13740869 , 13740870 , 13740871 , 13740872 , 13740873 , 13740874 , 13740875 , 13740876 , 13740877 , 13740878 , 13740879 , 13740880 , 13740881 , 13740882 , 13740883 , 13740884 , 13740885 , 13740886 , 13740887 , 13740888 , 13740889 , 13740890 , 13740891 , 13740892 , 13740893 , 13740894 , 13740895 , 13740896 , 13740897 , 13740898 , 13740899 , 13740900 , 13740901 , 13740902 , 13740903 , 13740904 , 13740905 , 13740906 , 13740907 , 13740908 , 13740909 , 13740910 , 13740911 , 13740912 , 13740913 , 13740914 , 13740915 , 13740916 , 13740917 , 13740918 , 13740919 , 13740920 , 13740921 , 13740922 , 13740923 , 13740924 , 13740925 , 13740926 , 13740927 , 13740928 , 13740929 , 13740930 , 13740977 , 13740980 , 13740982 , 13740986 , 13740994 , 13741025
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Croatia, Dominican Republic, Turks and Caicos.
  • Product Description
    Plum A+3 Infusion Pump System; || List Number: 12348; || Product Usage: || The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA