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
Product summary
- 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
anomaly in Medfusion 4000 Syringe Pump Firmware