令和 5年 7月18日作成
令和 5年 8月25日訂正(*)

一般的名称： 多人数用透析液供給装置
販売名　　： (1)多人数用透析液供給装置　DAB-NX
　　　　　　 (2)多人数用透析液供給装置　DAB-Si

型式　　　：DAB-70NX
製造番号　：
J1710375, J1710376, J1710377, J1712623, J1800895, J1801206, J1801329, J1801694, J1801878, J1802030, 
J1802486, J1802608, J1802622, J1802735, J1804255, J1804613, J1805125, J1805305, J1805331, J1805524, 
J1806712, J1806875, J1807079, J1807660, J1807915, J1809411, J1809589, J1809988, J1809990, J1810924, 
J1811847, J1812236, J1813269, J1901877, J1902494, J1903147, J1903748, J1903920, J1904312, J1904540, 
J1904689, J1906816, J1906818, J1907025, J1908070, J1914257, J1914258
数量　　　：47台
出荷時期　：2017年11月22日〜2020年8月27日

型式　　　：DAB-50Si
製造番号(*):
J1904217, J1904218, J1905730, J1905731, J1905915, J1906066, J1906067, J1906622, J1906623, J1907186, 
J1907187, J1907351, J1907352, J1907570, J1907571, J1907572, J1907811, J1907869, J1908045, J1908046, 
J1908511, J1908747, J1908748, J1908958, J1908959, J1908960, J1909126, J1909127, J1909128, J1909618, 
J1909619, J1909620, J1910139, J1910190, J1910191, J1910309, J1910387, J1910389, J1910599, J1910833, 
J1911064, J1911065, J1911066, J1911278, J1911279, J1911543, J1911544, J1911770, J1911771, J1911964, 
J1911965, J1911966, J1912150, J1912151, J1912152, J1912339, J1912340, J1912521, J1912522, J1912576, 
J1912715, J1912764, J1912765, J1912925, J1913067, J1913117, J1913118, J1913259, J1913260, J1913261, 
J1913449, J1913505, J1913648, J1913649, J1913709, J1913891, J1914102, J1914446, J1914447, J1914680, 
J1914696, J1914969, J1914970, J1915151, J1915199, J1915364, J1915365, J1915423, J1915557, J1915558, 
J1915777, J1915778, J1915779, J1915935, J1915937, J1916062, J1916063, J1916064, J2000114, J2000115, 
J2000233, J2000234, J2000235, J2000349, J2000350, J2000444, J2000446, J2000577, J2000578, J2000681, 
J2000682, J2000683, J2000832, J2000833, J2000934, J2000935, J2000936, J2001063, J2001206, J2001229, 
J2001358, J2001359, J2001505, J2001507, J2001854, J2002151, J2002285, J2002286, J2002470, J2002567, 
J2002568, J2002696, J2002697, J2002829, J2002839, J2002983, J2003239, J2003240, J2003350, J2003351, 
J2003352, J2003499, J2003500, J2003598, J2003731, J2003752, J2003848, J2003939, J2003940, J2004044, 
J2004116, J2004117, J2004181, J2004275, J2004339, J2004340, J2004411, J2004460, J2004466, J2004494, 
J2004495, J2004564, J2004612, J2004613, J2004684, J2004743, J2004744, J2004757, J2004818, J2004819, 
J2004828, J2004883, J2004884, J2004941, J2004993, J2004994, J2004995, J2005057, J2005058, J2005135, 
J2005136, J2005207, J2005208, J2005209, J2005288, J2005289, J2005341, J2005343, J2005397, J2005398, 
J2005457, J2005472, J2005538, J2005609, J2005656, J2005657, J2005658, J2005728, J2005729, J2005730, 
J2005788, J2005795, J2005848, J2005849, J2005850, J2005925, J2005926, J2005995, J2005996, J2006007, 
J2006053, J2006124, J2006125, J2006218, J2006219, J2006291, J2006376, J2006377, J2006388, J2006436, 
J2006448, J2006539, J2006540, J2006541, J2006660, J2006666, J2006792, J2006793, J2006797, J2006918, 
J2007061, J2007062, J2007063, J2007188, J2007189, J2057418, J2057419, J2057420, J2057505, J2057506, 
J2057568, J2057569, J2057570, J2057647, J2057648, J2057649, J2150095, J2150102, J2150260, J2150261, 
J2150262, J2150358, J2150359, J2150360, J2150444, J2150465, J2150565, J2150566, J2150567, J2150658, 
J2150686, J2150807, J2150827, J2150976, J2150977, J2150978, J2151105, J2151106, J2151245, J2151246, 
J2151401, J2151437, J2151438, J2151567, J2151568, J2151569, J2151742, J2151921, J2151922, J2152109, 
J2152110, J2152114, J2152275, J2152366, J2152367, J2152368, J2152570, J2152571, J2152572, J2152774, 
J2152775, J2152776, J2153024, J2153025, J2153026, J2153187, J2153188, J2153189, J2153457, J2153761, 
J2153762, J2153880, J2153881, J2153882, J2153883, J2154113, J2154116, J2154381, J2154382, J2154384, 
J2154506, J2154507, J2154734, J2154735, J2154736, J2154737, J2154885, J2154886, J2155020, J2155021, 
J2155022, J2155208, J2155209, J2155210, J2155442, J2155443, J2155444, J2155445, J2155644, J2155646, 
J2155647, J2155790, J2155791, J2155792, J2155793, J2156043, J2156044, J2156045, J2156046, J2156227, 
J2156228, J2156398, J2156399, J2156400, J2156401, J2156649, J2156650, J2156651, J2156652, J2156790, 
J2156944, J2156945, J2156946, J2156947, J2157168, J2157171, J2157284, J2157285, J2157286, J2157474, 
J2157675, J2157676, J2157677, J2157878, J2157880, J2158075, J2158076, J2158077, J2158257, J2158258, 
J2158259, J2158442, J2158443, J2158644, J2158645, J2158646, J2158647, J2158824, J2158825, J2159094, 
J2159095, J2159269, J2159272, J2159526, J2159527, J2159753, J2159988, J2159989, J2159990, J2160184, 
J2160185, J2160186, J2160488, J2160598, J2160599, J2160600, J2160755, J2160756, J2160757, J2160915, 
J2160916, J2160917, J2161090, J2161091, J2161274, J2161275, J2161276, J2161484, J2161485, J2161486, 
J2161682, J2161907, J2161908, J2161909, J2162133, J2162134, J2162135, J2162308, J2162309, J2162310, 
J2162496, J2162497, J2162498, J2162499, J2162798, J2162799, J2162826, J2162827, J2162828, J2163043, 
J2163045, J2163046, J2163047, J2163048, J2163209, J2163210, J2163211, J2163269, J2163272, J2163483, 
J2163484, J2163485, J2163553, J2163554, J2163748, J2163749, J2163750, J2163751, J2163993, J2163994, 
J2163995, J2163996, J2164236, J2164287, J2164288, J2164382, J2164383, J2164384, J2164410, J2250130, 
J2250131, J2250132, J2250133, J2250403, J2250404, J2250405, J2250406, J2250606, J2250607, J2250641, 
J2250642, J2250839, J2250840, J2250992, J2250993, J2251028, J2251093, J2251094, J2251111, J2251271, 
J2251307, J2251308, J2251375, J2251376, J2251394, J2251543, J2251559, J2251560, J2251761, J2251766, 
J2251903, J2251904, J2252043, J2252044, J2252236, J2252237, J2252393, J2252394, J2252536, J2252547, 
J2252680, J2252681, J2252815, J2252816, J2252817, J2252818, J2253177, J2253194, J2253302, J2253313, 
J2253314, J2253315, J2253468, J2253469, J2253471, J2253661, J2253668, J2253674, J2253796, J2253797, 
J2253973, J2253974, J2254168, J2254169, J2254408, J2254409, J2254580, J2254581, J2254582, J2254760, 
J2254761, J2254762, J2254763, J2255089, J2255090, J2255091, J2255095, J2255267, J2255268, J2255289, 
J2255503, J2255519, J2255520, J2255555, J2255788, J2255790, J2255922, J2255943, J2255944, J2255945, 
J2256112, J2256137, J2256138, J2256405, J2256406, J2256408, J2256662, J2256668, J2256669, J2256881, 
J2256882, J2256883, J2256887, J2257116, J2257117, J2257118, J2257348, J2257349, J2257415, J2257418, 
J2257623, J2257624, J2257625, J2257823, J2257824, J2257825, J2258080, J2258087, J2258244, J2258245, 
J2258275, J2258441, J2258442, J2258449, J2258450, J2258627, J2258628, J2258629, J2258822, J2258823, 
J2258848, J2258886, J2258997, J2258998, J2259034, J2259241, J2259242, J2259481, J2259482, J2259483, 
J2259755, J2259756, J2259757, J2260065, J2260078, J2260355, J2260356, J2260393, J2260664, J2260665, 
J2261063, J2261064, J2261065, J2261202, J2261203, J2261227, J2261421, J2261439, J2261453, J2261684, 
J2261685, J2261890, J2261891, J2261892, J2262124, J2262334, J2262367, J2262368, J2262654, J2262927, 
J2262928, J2262929, J2263151, J2263193, J2263364, J2263365, J2263410, J2263600, J2263601, J2263749, 
J2263750, J2264255, J2264256, J2264410, J2264411, J2264412, J2264594, J2264595, J2264596, J2264811, 
J2264833, J2265033, J2265685, J2265735, J2265736, J2265967, J2350001, J2350002, J2350003, J2350218, 
J2350225, J2350542, J2350543, J2350554, J2350803, J2350804, J2350805, J2351246, J2351486, J2351503, 
J2351504, J2351675, J2351676, J2351683, J2352036, J2352037, J2352228, J2352477, J2352661, J2352672, 
J2352719, J2352721, J2352883, J2352884, J2353236, J2353237, J2353238, J2353239, J2353629, J2353986, 
J2353987, J2353988, J2353994, J2354322, J2354323, J2354324, J2354325, J2354642, J2354663, J2354813, 
J2354814, J2354846, J2355146, J2355147, J2355148, J2355408, J2355444, J2355639, J2355640, J2355873, 
J2355907, J2355908, J2356600, J2356601, J2357460
数量(*) 　：715台
出荷時期　：2019年6月6日〜2023年6月8日

型式　　　：DAB-70Si
製造番号　：
J1905729, J1906624, J1907188, J1907353, J1907812, J1908512, J1908743, J1910665, J1910782, J1911280, 
J1911772, J1912341, J1912927, J1913450, J1913860, J1914091, J1914494, J1914679, J1914968, J1915152, 
J1915564, J1915936, J2000116, J2000336, J2000549, J2000826, J2001060, J2001691, J2001692, J2001855, 
J2002008, J2002009, J2002152, J2002442, J2002982, J2003105, J2003249, J2003604, J2003847, J2003941, 
J2004050, J2004184, J2004274, J2004412, J2004563, J2004694, J2004942, J2005059, J2005142, J2005292, 
J2005342, J2005399, J2005471, J2005539, J2005608, J2005789, J2005927, J2006054, J2006136, J2006220, 
J2006292, J2006293, J2006447, J2006659, J2006989, J2006990, J2007177, J2057507, J2150085, J2150466, 
J2150687, J2150826, J2151104, J2151236, J2151741, J2151743, J2151923, J2152115, J2152267, J2152278, 
J2153458, J2153459, J2153587, J2153763, J2154114, J2154115, J2154383, J2154508, J2154509, J2154887, 
J2154888, J2155019, J2155211, J2155645, J2156225, J2156226, J2156791, J2156793, J2157169, J2157170, 
J2157472, J2157473, J2157879, J2158441, J2158460, J2158826, J2158827, J2159093, J2159096, J2159270, 
J2159271, J2159528, J2159529, J2159754, J2159755, J2160486, J2160487, J2161092, J2161683, J2161684, 
J2164220, J2251029, J2251110, J2251309, J2251762, J2251763, J2251930, J2252053, J2252238, J2252415, 
J2252548, J2252702, J2253193, J2253200, J2253470, J2253662, J2253803, J2253810, J2253971, J2253972, 
J2254177, J2254178, J2254427, J2254428, J2254583, J2255282, J2255787, J2255789, J2256113, J2256407, 
J2256648, J2257089, J2257626, J2257882, J2258091, J2258626, J2259282, J2260052, J2260663, J2261653, 
J2262131, J2262132, J2262665, J2262671, J2263163, J2264043, J2264044, J2264226, J2265966, J2265968, 
J2350219, J2351250, J2351294, J2351996, J2352231, J2352232, J2352476, J2352478, J2352853, J2352890, 
J2353601, J2353602, J2354643, J2356155, J2356602
数量　　　：185台
出荷時期　：2019年6月13日〜2023年5月24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

給水電磁弁のコネクタ部において、圧着端子の変形が確認されました。調査の結果、検査に用いる治具が変形し
ており、本不具合が発生していることが判明しました。圧着端子が変形している場合、圧着端子の接触が不安定
になり、導通不良により送液が停止する可能性があることから、点検を実施し、不具合を認めた場合は部品を交
換する自主改修を行うことにいたしました。

本装置は、患者の治療に使用される透析用監視装置に透析液を供給する装置です。本事象が発生した場合、透析
用監視装置が停止して警報を発します。このため、医療従事者は本装置の異常に気づくことができます。したが
いまして、重篤な健康被害の発生には至らないと考えております。なお、これまでに本事象に関する健康被害の
報告は受けておりません。

令和5年7月18日

人工腎臓により血液透析を行うために透析液を作製し、2人以上の患者に供給する。

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　： 奥村典子、上田義郎
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