Recalls / —

—#177807

Product

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA product code

FRN — Pump, Infusion

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K111386

Affected lot / code info

Serial numbers: 2039045, 2039062, 2039082, 2039084, 2039093, 2039122, 2039128, 2039132, 2039133, 2039137, 2039145, 2039151, 2039153, 2039158, 2039164, 2039174, 2039178, 2039181, 2039182, 2039183, 2039187, 2039202, 2039203, 2039204, 2039208, 2039209, 2039210, 2039211, 2039212, 2039216, 2039217, 2039220, 2039221, 2039223, 2039225, 2039226, 2039228, 2039231, 2039232, 2039234, 2039235, 2039236, 2039238, 2039239, 2039246, 2039247, 2039248, 2039250, 2039252, 2039259, 2039290, 2039291, 2039292, 2039295, 2039305, 2039307, 2039308, 2039312, 2039313, 2039315, 2039317, 2039323, 2039325, 2039360, 2039373, 2039394, 2039407, 2039416, 2039419, 2039420, 2039422, 2039435, 2039437, 2039446, 2039453, 2039456, 2039460, 2039461, 2039462, 2039463, 2039464, 2039465, 2039466, 2039469, 2039473, 2039478, 2039483, 2039485, 2039487, 2039490, 2039494, 2039502, 2039503, 2039516, 2039517, 2039545, 2039551, 2039904, 2039910, 2039970, 2040014, 2040029, 2040034, 2040040, 2040047, 2040050, 2040054, 2040068, 2040074, 2040082, 2040091, 2040107, 2040108, 2040140, 2040159, 2040173, 2040191, 2040201, 2040203, 2040205, 2040206, 2040228, 2040231, 2040238, 2040241, 2040255, 2040260, 2040261, 2040271, 2040273, 2040322, 2040323, 2040336, 2040340, 2040383, 2040387, 2040388, 2040390, 2040392, 2040406, 2040411, 2040414, 2040421, 2040422, 2040425, 2040426, 2040432, 2040433, 2040435, 2040437, 2040438, 2040439, 2040441, 2040474, 2040587, 2040601, 2040603, 2040606, 2040610, 2040613, 2040623, 2040663, 2040680, 2040684, 2040699, 2040704, 2040713, 2040715, 2040716, 2040717, 2040718, 2040720, 2040721, 2040722, 2040723, 2040724, 2040726, 2040727, 2040729, 2040730, 2040731, 2040732, 2040733, 2040735, 2040736, 2040737, 2040738, 2040739, 2040740, 2040743, 2040744, 2040746, 2040747, 2040752, 2040757, 2040762, 2040765, 2040773, 2040774, 2040775, 2040776, 2040777, 2040782, 2040786, 2040791, 2040799, 2040802, 2040803, 2040804, 2040805, 2040806, 2040808, 2040809, 2040810, 2040812, 2040813, 2040815, 2040817, 2040818, 2040823, 2040824, 2040832, 2040833, 2040839, 2040872, 2040873, 2040888, 2040889, 2040890, 2040891, 2040902, 2040913, 2040917, 2040935, 2040939, 2040941, 2040942, 2040943, 2040952, 2040953, 2040954, 2040955, 2040958, 2040959, 2040976, 2040987, 2040992, 2040997, 2041033, 2041176, 2041177, 2041183, 2041187, 2041190, 2041191, 2041192, 2041195, 2041198, 2041199, 2041200, 2041201, 2041202, 2041204, 2041205, 2041206, 2041207, 2041209, 2041211, 2041212, 2041214, 2041215, 2041216, 2041217, 2041218, 2041222, 2041224, 2041225, 2041226, 2041229, 2041230, 2041231, 2041234, 2041235, 2041236, 2041237, 2041238, 2041239, 2041241, 2041242, 2041243, 2041244, 2041245, 2041247, 2041248, 2041250, 2041251, 2041252, 2041253, 2041254, 2041255, 2041256, 2041258, 2041259, 2041260, 2041261, 2041262, 2041263, 2041264, 2041265, 2041266, 2041268, 2041269, 2041270, 2041271, 2041272, 2041273, 2041274, 2041275, 2041276, 2041279, 2041280, 2041281, 2041283, 2041284, 2041285, 2041287, 2041288, 2041290, 2041291, 2041292, 2041293, 2041294, 2041296, 2041297, 2041299, 2041301, 2041302, 2041303, 2041306, 2041307, 2041309, 2041310, 2041311, 2041312, 2041315, 2041316, 2041318, 2041319, 2041320, 2041321, 2041322, 2041324, 2041326, 2041328, 2041330, 2041331, 2041332, 2041333, 2041334, 2041336, 2041338, 2041339, 2041340, 2041341, 2041342, 2041343, 2041344, 2041345, 2041346, 2041348, 2041350, 2041351, 2041353, 2041354, 2041356, 2041358, 2041359, 2041360, 2041361, 2041362, 2041364, 2041366, 2041367, 2041369, 2041370, 2041372, 2041373, 2041374, 2041375, 2041376, 2041377, 2041379, 2041380, 2041382, 2041383, 2041384, 2041386, 2041387, 2041388, 2041389, 2041390, 2041393, 2041394, 2041395, 2041396, 2041398, 2041401, 2041402, 2041405, 2041406, 2041407, 2041409, 2041410, 2041412, 2041413, 2041414, 2041416, 2041417, 2041418, 2041419, 2041420, 2041421, 2041422, 2041423, 2041424, 2041426, 2042293, 2042482, 2042483, 2042484, 2042486, 2042487, 2042489, 2042490, 2042491, 2042492, 2042493, 2042495, 2042497, 2042501, 2042505, 2042506, 2042509, 2042513, 2042514, 2042516, 2042518, 2042519, 2042520, 2042521, 2042522, 2042525, 2042526, 2042528, 2042529, 2042531, 2042532, 2042533, 2042535, 2042539, 2042540, 2042546, 2042547, 2042548, 2042550, 2042553, 2042556, 2042561, 2042564, 2042567, 2042568, 2042579, 2042582, 2042584, 2042587, 2042588, 2042589, 2042590, 2042594, 2042600, 2042603, 2042608, 2042609, 2042610, 2042615, 2042617, 2042618, 2042619, 2042622, 2042628, 2042629, 2042630, 2042633, 2042635, 2042639, 2042641, 2042642, 2042643, 2042644, 2042645, 2042646, 2042650, 2042651, 2042652, 2042653, 2042655, 2042666, 2042672, 2042673, 2042676, 2042678, 2042680, 2042682, 2042683, 2042684, 2042685, 2042688, 2042690, 2042692, 2042693, 2042696, 2042698, 2042699, 2042700, 2042703, 2042705, 2042707, 2042709, 2042713, 2042714, 2042715, 2042716, 2042717, 2042720, 2042721, 2042723, 2042724, 2042725, 2042728, 2042729, 2042730, 2042731, 2042732, 2042733, 2042734, 2042736, 2042737, 2042738, 2042739, 2042740, 2042741, 2042742, 2042745, 2042746, 2042747, 2042748, 2042750, 2042753, 2042754, 2042755, 2042756, 2042758, 2042759, 2042760, 2042761, 2042762, 2042763, 2042767, 2042769, 2042770, 2042771, 2042772, 2042774, 2042778, 2042779, 2042780, 2042781, 2042785, 2042787, 2042791, 2042794, 2042795, 2042805, 2042806, 2042807, 2042809, 2042810, 2042815, 2043264, 2043265, 2043266, 2043267, 2043268, 2043269, 2043270, 2046025, 2046026, 2046027, 2046028, 2046029, 2046030, 2046031, 2046032, 2046033, 2046034, 2046035, 2046036, 2046037, 2046038, 2046039, 2046040, 2046041, 2046042, 2046043, 2046044, 2046045, 2046046, 2046047, 2046048, 2046049, 2046050, 2046051, 2046052, 2046053, 2046054, 2046055, 2046056.

Why it was recalled

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

Root cause (FDA determination)

Software design

Action the firm took

An Urgent Medical Device recall letter dated 10/28/2019 was sent to customers via email beginning 10/28/2019. The letter identified affected product, stated the issue, and provided instructions for customers to return the pumps. A response form was asked to be returned. Questions can be directed to fieldactions@smiths-medical.com.

Recalling firm

Firm

Smiths Medical ASD Inc.

Address

6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern

CO, MD, NY

Timeline

Recall initiated

2019-10-28

Posted by FDA

2019-12-12

Terminated

2024-06-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #177807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.