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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion 4000 Syringe Infusion Pump with Smart Pump Programming Enabed

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 Class 2 Device Recall Medfusion 4000 Syringe Infusion Pump with Smart Pump Programming Enabedsee related information
Date Initiated by FirmOctober 10, 2022
Date PostedNovember 21, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0272-2023
Recall Event ID 91052
510(K)NumberK111386 
Product Classification Pump, infusion - Product Code FRN
ProductMedfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
Code Information Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846 2033850 2033851 2033852 2033854 2033856 2033857 2033858 2033859 2033861 2033862 2033864 2033865 2033866 2033867 2033871 2033875 2033877 2033878 2033880 2033982 2033984 2034104 2034106 2034107 2034108 2034109 2034110 2034113 2034115 2034116 2034117 2034118 2034120 2034123 2034124 2034125 2034126 2034129 2034131 2034132 2034133 2034134 2034135 2034136 2034137 2034138 2034139 2034140 2034141 2034142 2034143 2034144 2034145 2034146 2034147 2034148 2034149 2034150 2034151 2034152 2034153 2034154 2034155 2034201 2034202 2034204 2034205 2034222 2034223 2034224 2034225 2035182 2035183 2035184 2035185 2035186 2035187 2035188 2035190 2035191 2035193 2035194 2035195 2035196 2035197 2035198 2035200 2035201 2035202 2035203 2035204 2035205 2035206 2035207 2035209 2035210 2035212 2035214 2035216 2035217 2035218 2035811 2035812 2035813 2035814 2035815 2035816 2035817 2035819 2035820 2035821 2035826 2035827 2035828 2035829 2035830 2035832 2035851 2035852 2035853 2035854 2037161 2033881 2033981 2038674 2038675 2038676 2038677 2038678 2038679 2038680 2038681 2038683 2038685 2038686 2038687 2038688 2038689 2038690 2038691 2038692 2038693 2038694 2038695 2038696 2035850 2034112 2034114 2034121 2035818 2033855 2034119 2035189 2035211 2033849 2035192 2035199 2035208 2035809 2035822 2035824 2035810 2035808 2035825 2035823 2035831 2038682 2033872 2033869 2033874 2033860 2025796 2025826 2046165 2046167 2046168 2046169 2046170 2046171 2046172 2046173 2046174 2046175 2046176 2046177 2046178 2046179 2046181 2046182 2046185 2025809 2038684 2033876 2067955 2067957 2067960 2067961 2067963 2067964 2067965 2067966 2067967 2067968 2067969 2067971 2067972 2067973 2067974 2067975 2067976 2067978 2067980 2067981 2067982 2067983 2067984 2067985 2067987 2067989 2067991 2067993 2067994 2067995 2067996 2067997 2067998 2067999 2068000 2068001 2068003 2068007 2068008 2068010 2068011 2068012 2068013 2068014 2068015 2068017 2068019 2068021 2068022 2068023 2068024 2068025 2068027 2068028 2068029 2068031 2068032 2068033 2068034 2068037 2068038 2068039 2068040 2068042 2068043 2068044 2068046 2068048 2068049 2068053 2068054 2068055 2068056 2068058 2068059 2068060 2068061 2068062 2068063 2068064 2068065 2068067 2068068 2068069 2068071 2068072 2068073 2068077 2068078 2068079 2068081 2068082 2068083 2068084 2068085 2068086 2068088 2068089 2068090 2068091 2068092 2068093 2068094 2068096 2068097 2068098 2068099 2068100 2068102 2068103 2068106 2068107 2068108 2068109 2068110 2068111 2068112 2068113 2068114 2068115 2068116 2068117 2068118 2068272 2068516 2068517 2068518 2068519 2068535 2068536 2068543 2068547 2068549 2069708 2069709 2069710 2068651 2068652 2068741 2068742 2068772 2067992 2068857 2068881 2068938 2068939 2068940 2068943 2068944 2068945 2068946 2035213 2069381 2069431 2069432 2069433 2067970 2068941 2068035 2068020 2046180 2068075 2070960 2068005 2068080 2070972 2070973 2068548 2068004 2068786 2068653 2033879 2068006 2068045 2068937 2068942 2068030 2068105 2068544 2068052 2068009 2068066 2046184 2068047 2068076 2033847 2069434 2068104 2068041 2033870 2068050 2046183 2067959 2033848 2034206 2033853 2025806 2025812 UDI: 501951707075; Serial #'s 2028673 2044037 2020917 2032957 2037477 2040070 2041392 2041527 2041668 2049487 2006685 2006717 2006750 2008582 2008620 2047401 2049022 2049927 2049932 2049934 2049941 2060111 2060405 2060441 2061199 2067962 2067977 2067988
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
FDA Determined
Cause 2		Under Investigation by firm
ActionSmiths Medical notified consignees initially via telephone on 10/10/2022 and followed up with a letter via email on 10/11/2022. The letter was titled "URGENT MEDICAL DEVICE CORRECTION" and instructed consignees to locate all affected pumps and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations, complete and return the attached Response Form to fieldactions@smiths-medical.com, and if Smiths Medical does not contact you to schedule the implementation of the software updates, please contact Smiths Medical Technical Assistance. For further inquiries, please contact Smiths Medical using the following information: email: MedfusionFieldCorrections@icumed.com.
Quantity in Commerce422 devices
DistributionUS distribution to states of: Indiana, Texas and Virginia
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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