令和元年 8月 8日作成
令和 2年 3月30日訂正(*)
令和 2年12月 9日訂正(**)

一般的名称： (1)〜(2)多用途透析装置
販売名　　： (1)多用途透析用監視装置　DCS-100NX
　　　　　　 (2)個人用多用途透析装置　DBB-100NX

72549-04, 72549-05, 72550-03, 72550-04, 72551-02, 72603-05, 72631-01, 72649-01, 72649-02, 72649-03, 
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J1900926, J1900927, J1900928, J1900929, J1900930, J1900931, J1900932, J1900933, J1900934, J1900935, 
J1900936, J1900937, J1900938, J1900939, J1900940, J1900941, J1900942, J1900943, J1900949, J1900950, 
J1900951, J1900952, J1900953, J1900954, J1900955, J1900956, J1900957, J1900987, J1900988, J1900989, 
J1900990, J1900991, J1900992, J1900993, J1901012, J1901013, J1901014, J1901015, J1901016, J1901017, 
J1901018, J1901019, J1901020, J1901021, J1901022, J1901023, J1901024, J1901025, J1901026, J1901027, 
J1901028, J1901029, J1901030, J1901031, J1901032, J1901033, J1901034, J1901035, J1901039, J1901040, 
J1901041, J1901042, J1901043, J1901044, J1901045, J1901046, J1901047, J1901048, J1901058, J1901059, 
J1901060, J1901061, J1901062, J1901063, J1901064, J1901065, J1901066, J1901067, J1901068, J1901069, 
J1901070, J1901071, J1901072, J1901073, J1901074, J1901075, J1901076, J1901077, J1901078, J1901079, 
J1901080, J1901081, J1901115, J1901121, J1901122, J1901123, J1901124, J1901125, J1901126, J1901127, 
J1901128, J1901129, J1901130, J1901131, J1901132, J1901133, J1901134, J1901135, J1901136, J1901137, 
J1901138, J1901139, J1901140, J1901161, J1901162, J1901163, J1901164, J1901165, J1901166, J1901167, 
J1901168, J1901181, J1901182, J1901184, J1901185, J1901186, J1901187, J1901188, J1901189, J1901190, 
J1901191, J1901192, J1901193, J1901194, J1901195, J1901211, J1901212, J1901213, J1901214, J1901215, 
J1901216, J1901217, J1901218, J1901219, J1901220, J1901221, J1901222, J1901223, J1901224, J1901225, 
J1901226, J1901227, J1901228, J1901229, J1901230, J1901231, J1901232, J1901246, J1901247, J1901248, 
J1901249, J1901250, J1901251, J1901252, J1901253, J1901254, J1901255, J1901256, J1901257, J1901258, 
J1901259, J1901260, J1901261, J1901262, J1901263, J1901264, J1901275, J1901276, J1901277, J1901278, 
J1901279, J1901280, J1901281, J1901282, J1901283, J1901284, J1901285, J1901286, J1901287, J1901288, 
J1901289, J1901307, J1901308, J1901309, J1901310, J1901311, J1901312, J1901313, J1901314, J1901315, 
J1901316, J1901317, J1901318, J1901329, J1901330, J1901331, J1901332, J1901333, J1901334, J1901335, 
J1901336, J1901337, J1901338, J1901339, J1901340, J1901341, J1901342, J1901343, J1901344, J1901345, 
J1901346, J1901357, J1901358, J1901359, J1901360, J1901382, J1901383, J1901384, J1901385, J1901386, 
J1901387, J1901388, J1901389, J1901390, J1901391, J1901392, J1901393, J1901394, J1901395, J1901396, 
J1901397, J1901398, J1901399, J1901413, J1901414, J1901415, J1901416, J1901417, J1901418, J1901419, 
J1901420, J1901421, J1901422, J1901423, J1901424, J1901425, J1901426, J1901427, J1901428, J1901434, 
J1901435, J1901436, J1901437, J1901438, J1901439, J1901450, J1901451, J1901452, J1901453, J1901454, 
J1901455, J1901456, J1901457, J1901458, J1901459, J1901460, J1901461, J1901462, J1901463, J1901464, 
J1901465, J1901466, J1901467, J1901484, J1901491, J1901492, J1901493, J1901494, J1901495, J1901496, 
J1901497, J1901498, J1901499, J1901506, J1901507, J1901508, J1901509, J1901525, J1901526, J1901527, 
J1901528, J1901529, J1901530, J1901531, J1901532, J1901533, J1901534, J1901535, J1901536, J1901542, 
J1901543, J1901544, J1901545, J1901546, J1901547, J1901548, J1901549, J1901550, J1901551, J1901552, 
J1901553, J1901554, J1901555, J1901561, J1901562, J1901563, J1901564, J1901575, J1901576, J1901577, 
J1901578, J1901607, J1901608, J1901609, J1901610, J1901611, J1901612, J1901613, J1901614, J1901615, 
J1901616, J1901617, J1901618, J1901619, J1901620, J1901621, J1901622, J1901623, J1901624, J1901625, 
J1901626, J1901627, J1901628, J1901630, J1901631, J1901632, J1901633, J1901634, J1901635, J1901637, 
J1901638, J1901639, J1901640, J1901641, J1901642, J1901663, J1901664, J1901665, J1901666, J1901667, 
J1901668, J1901669, J1901670, J1901671, J1901672, J1901673, J1901674, J1901717, J1901718, J1901719, 
J1901720, J1901726, J1901727, J1901728, J1901729, J1901730, J1901731, J1901732, J1901733, J1901734, 
J1901735, J1901736, J1901737, J1901738, J1901739, J1901740, J1901741, J1901742, J1901743, J1901744, 
J1901745, J1901746, J1901747, J1901748, J1901749, J1901750, J1901751, J1901752, J1901753, J1901754, 
J1901755, J1901766, J1901767, J1901768, J1901794, J1901795, J1901796, J1901797, J1901798, J1901799, 
J1901800, J1901801, J1901802, J1901803, J1901804, J1901805, J1901806, J1901807, J1901808, J1901809, 
J1901810, J1901811, J1901812, J1901839, J1901840, J1901841, J1901842, J1901843, J1901844, J1901845, 
J1901846, J1901847, J1901848, J1901849, J1901850, J1901851, J1901852, J1901853, J1901854, J1901855, 
J1901856, J1901857, J1901858, J1901859, J1901860, J1901862, J1901863, J1901864, J1901865, J1901866, 
J1901867, J1901868, J1901869, J1901870, J1901871, J1901872, J1901873, J1901885, J1901886, J1901887, 
J1901888, J1901889, J1901890, J1901891, J1901892, J1901893, J1901894, J1901912, J1901913, J1901914, 
J1901915, J1901916, J1901917, J1901918, J1901919, J1901920, J1901921, J1901922, J1901923, J1901924, 
J1901925, J1901926, J1901927, J1901928, J1901929, J1901938, J1901939, J1901940, J1901941, J1901946, 
J1901947, J1901948, J1901949, J1901950, J1901951, J1901952, J1901953, J1901954, J1901955, J1901956, 
J1901957, J1901958, J1901959, J1901960, J1901961, J1901962, J1901963, J1901997, J1901998, J1901999, 
J1902000, J1902001, J1902002, J1902003, J1902004, J1902005, J1902006, J1902011, J1902017, J1902066, 
J1902067, J1902068, J1902069, J1902071, J1902072, J1902073, J1902074, J1902075, J1902076, J1902077, 
J1902085, J1902086, J1902087, J1902088, J1902089, J1902090, J1902091, J1902092, J1902093, J1902094, 
J1902095, J1902096, J1902117, J1902118, J1902119, J1902120, J1902121, J1902122, J1902123, J1902124, 
J1902125, J1902126, J1902127, J1902128, J1902129, J1902130, J1902131, J1902132, J1902133, J1902134, 
J1902135, J1902136, J1902137, J1902138, J1902139, J1902140, J1902152, J1902153, J1902154, J1902155, 
J1902156, J1902157, J1902176, J1902177, J1902178, J1902179, J1902180, J1902181, J1902182, J1902183, 
J1902184, J1902185, J1902186, J1902187, J1902188, J1902189, J1902190, J1902191, J1902192, J1902193, 
J1902217, J1902218, J1902219, J1902220, J1902223, J1902289, J1902290, J1902291, J1902292, 
71164-01(*), 71164-02(*), 71164-03(*), 72011-01(*), 72011-02(*), 72642-05(*), 72712-03(*), 
72867-05(*), J1305072(*), J1310205(*), J1310206(*), J1310207(*), J1310208(*), J1310209(*), 
J1310210(*), J1310211(*), J1310212(*), J1310213(*), J1310214(*), J1310215(*), J1310216(*), 
J1310217(*), J1310218(*), J1310219(*), J1310220(*), J1310221(*), J1310222(*), J1403415(*), 
J1403416(*), J1403417(*), J1403418(*), J1403419(*), J1408103(*), J1408104(*), J1408105(*), 
J1408106(*), J1410378(*), J1410379(*), J1410380(*), J1410381(*), J1410382(*), J1410384(*), 
J1410385(*), J1410386(*), J1502525(*), J1502526(*), J1502527(*), J1502528(*), J1502529(*), 
J1611466(*), J1611467(*), J1611468(*), J1901579(*), J1901895(*), J1901896(*), J1902012(*), 
J1902013(*), J1902014(*), J1902015(*), J1902016(*), J1902042(*), J1902043(*), J1902044(*), 
J1902045(*), J1902046(*), J1902047(*), J1902055(*), J1902056(*), J1902057(*), J1902058(*), 
J1902059(*), J1902060(*)
数量　　 ：3,811台(**)
出荷時期 ：平成30年8月23日〜令和元年10月25日(*)

(2)　個人用多用途透析装置　DBB-100NX
製造番号 ：
J1807779, J1807780, J1807922, J1807954, J1807955, J1808189, J1808190, J1808191, J1808192, J1808415, 
J1808416, J1808417, J1808418, J1808419, J1808620, J1808621, J1808622, J1808623, J1808624, J1808644, 
J1808854, J1808855, J1808856, J1808857, J1808858, J1808871, J1808872, J1808873, J1809068, J1809069, 
J1809070, J1809071, J1809072, J1809073, J1809269, J1809270, J1809271, J1809272, J1809273, J1809278, 
J1809444, J1809445, J1809446, J1809620, J1809659, J1809660, J1809661, J1809679, J1809680, J1809825, 
J1809844, J1809845, J1809846, J1809852, J1810046, J1810052, J1810070, J1810293, J1810294, J1810295, 
J1810303, J1810304, J1810305, J1810497, J1810498, J1810499, J1810507, J1810621, J1810644, J1810645, 
J1810654, J1810655, J1810797, J1810818, J1810819, J1810820, J1811005, J1811012, J1811013, J1811014, 
J1811015, J1811201, J1811202, J1811203, J1811204, J1811205, J1811206, J1811207, J1811373, J1811374, 
J1811375, J1811377, J1811378, J1811379, J1811386, J1811547, J1811548, J1811549, J1811555, J1811724, 
J1811726, J1811727, J1811734, J1811735, J1811736, J1811743, J1811744, J1811745, J1811746, J1811747, 
J1811928, J1811929, J1811930, J1811931, J1811946, J1811947, J1811948, J1811949, J1811950, J1811951, 
J1811952, J1812099, J1812100, J1812101, J1812102, J1812103, J1812141, J1812142, J1812296, J1812331, 
J1812339, J1812340, J1812345, J1812497, J1812501, J1812509, J1812510, J1812516, J1812519, J1812702, 
J1812703, J1812704, J1812741, J1812742, J1812743, J1812744, J1812745, J1812746, J1812747, J1812926, 
J1812932, J1812945, J1812958, J1812959, J1812960, J1812961, J1813147, J1813148, J1813149, J1813150, 
J1813175, J1813176, J1813177, J1813381, J1813418, J1813419, J1813420, J1813421, J1813422, J1813423, 
J1813752, J1813753, J1813754, J1813893, J1813925, J1813938, J1814090, J1814091, J1814116, J1814117, 
J1814118, J1900010, J1900011, J1900054, J1900055, J1900056, J1900199, J1900200, J1900213, J1900237, 
J1900238, J1900367, J1900368, J1900393, J1900410, J1900411, J1900567, J1900568, J1900717, J1900718, 
J1900719, J1900720, J1900764, J1900958, J1900974, J1900985, J1900986, J1900994, J1901145, J1901179, 
J1901180, J1901366, J1901367, J1901368, J1901369, J1901370, J1901556, J1901557, J1901558, J1901559, 
J1901560, J1901813, J1901814, J1901815, J1901816, J1901827, J1901992, J1901993, J1901994, J1901995, 
J1902216, J1902222
J1304303(*), J1507901(*), J1507902(*), J1508474(*), J1810500(*), J1810620(*), J1810795(*), 
J1811004(*), J1811912(*), J1812502(*), J1812503(*), J1812927(*), J1812928(*), J1812930(*), 
J1813151(*), J1813152(*), J1813382(*), J1813750(*), J1813907(*), J1900569(*), J1511985(**)
数量　　 ：253台(**)
出荷時期 ：平成30年8月24日〜令和元年7月4日(*)

製造販売業者の名称　： 日機装株式会社
製造販売業者の所在地： 東京都渋谷区恵比寿四丁目20番3号 恵比寿ガーデンプレイスタワー
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00153

医療機関より、治療中に静脈側ラインへ血液が上昇する、または静脈圧が上がらないとの報告を受けました。調
査の結果、装置内部の静脈側エア配管に使用しているチューブ組立のエアフィルタが破損し、エア漏れが発生し
ていることが分かりました。
2018年8月に当該部品の組立作業を変更しており、エアフィルタにオスコネクタを挿入する際に過度な力が掛か
り、エアフィルタ部に残る応力が作用して亀裂に至ったものと判断しました。エアフィルタへの挿入を最適化し
たものに変更する自主改修を行うことと致しました。

当該事象が発生した場合、血液回路の静脈圧ラインに血液が上昇する、または静脈圧が上がらなくなります。
医療従事者は異常にすぐ気づき、適切に処置することができるため、患者に重篤な健康被害につながる可能性は
ないと考えられます。
個人用多用途透析装置 DBB-100NXは医療機関の判断のもと、在宅血液透析用装置として用いられることがありま
す。在宅血液透析を行う場合、医療機関は患者および介助者に緊急時の対応も含め、十分な教育訓練を行ってい
ます。そのため、当該事象が発生した場合は血液ポンプを止めて医療機関へ連絡する対応が取られるため、重篤
な健康被害につながる可能性はないと考えられます。
なお、これまでに本事象に関する健康被害発生の報告は受けておりません。

令和元年8月8日

本装置は、慢性又は急性腎不全など腎機能が著しく低下した症例の血液透析（HD）、血液透析ろ過（HDF）又は
血液ろ過（HF）治療において、透析液（温度等）の監視、除水、補液及び血液体外循環の制御及び監視に使用す
る。

出荷先は全て把握しており、出荷先に対して自主改修を行う旨を文書で通知した上、自主改修を行います。

担当者　： 森山　宏樹(**)
連絡先　： 日機装株式会社
　　　　　 東京都渋谷区恵比寿4丁目20番3号
電話番号： 03-3443-3754
FAX番号 ： 03-3473-4965