Class 2 Device Recall Plum A3 Infusion Pump System

• Date Initiated by Firm: February 01, 2013
• Date Posted: November 14, 2013
• Recall Status: Terminated on December 06, 2016
• Recall Number: Z-0286-2014
• Recall Event ID: 64263
• 510(K)Number: K021350
• Product Classification: Pump, infusion - Product Code FRN
• Product: The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+3 Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
• Code Information: 1) List Number 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
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Hospira Global Complaint Management; 800-441-4100
• Manufacturer Reason for Recall: Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken
• FDA Determined Cause: Component design/selection
• Action: Hospira sent an Urgent Device Field Correction letter dated February 1, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter recommends that facilities immediately visually inspect their Plum a+ devices to determine if the distal pressure pin is broken or damaged via instructions included in the letter. If a broken or damaged distal pressure pin is observed, remove the device from service and contact Hospira at 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to report the issue. If the return of defective pumps significantly impairs a facility's ability to operate normally, Hospira will provide loaner pumps. The letter also encourages customers to insert cassettes into pumps in accordance with the instructions found in the operator's manual. Customers were asked to complete the attached reply form and return it via fax to the number on the form. Customers with questions were instructed to call 1-800-441-4100 or 1-800-241-4002, option 4. The letter also asked direct accounts that further distributed the pumps notify their customers of the URGENT DEVICE FIELD CORRECTION and ask them to contact Stericycle at 1-866-201-9068 to receive a reply form.. For questions regarding this recall call 800-441-4100,
• Quantity in Commerce: 214 units
• 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN