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Recall Observatory FDA recall evidence

Device 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.

Z-0610-2020

October 28, 2019

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 84232
Status
Terminated
Classification
Class I
Quantity
626 devices
Official record key
device-enforcement:Z-0610-2020

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: CO, MD, NY

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    anomaly in Medfusion 4000 Syringe Pump Firmware