令和元年 5月 9日作成

一般的名称： 自動腹膜灌流用装置
販売名　　： ホームPDシステム かぐや

製造番号：
727080037,727080040,727080043,727080048,727080049,727080050,727080051,727080052,727080053,727080054,
727080055,727080056,727080057,727080058,728020001,728020002,728020003,728020004,728020005,728020006,
728020007,728020008,728020009,728020010,728020011,728020012,728020013,728020014,728020015,728020016,
728020017,728020018,728020019,728020020,728020021,728020022,728020023,728020024,728020025,728020026,
728020027,728020028,728020029,728020030,728020031,728020032,728020033,728020034,728020035,728020036,
728020037,728020038,728020039,728020040,728020041,728020042,728020043,728020044,728020045,728020046,
728020047,728020048,728020049,728020050,728020051,728020052,728020053,728020054,728020055,728020056,
728020057,728020058,728020059,728020060,728020061,728020062,728030001,728030002,728030003,728030004,
728030005,728030006,728030007,728030008,728030009,728030010,728030011,728030012,728030013,728030014,
728030015,728030016,728030017,728030018,728030019,728030020,728030021,728030022,728030023,728030024,
728030025,728030026,728030027,728030028,728030029,728030030,728030031,728030032,728030033,728030034,
728030035,728030036,728030037,728030038,728030039,728030040,728030041,728030042,728030043,728030044,
728030045,728030046,728030047,728030048,728050001,728050002,728050003,728050004,728050005,728050006,
728050007,728050008,728050009,728050010,728050011,728050012,728050013,728050014,728050015,728050016,
728050017,728050018,728050019,728050020,728050021,728050022,728050023,728050024,728050025,728050026,
728050027,728050028,728050029,728050030,728050031,728050032,728050033,728050034,728050035,728050036,
728050037,728050038,728050039,728050040,728050041,728050042,728050043,728050044,728050045,728050046,
728050047,728050048,728050049,728050050,728050051,728050052,728050053,728050054,728050055,728050056,
728050057,728050058,728050059,728050060,728050061,728050062,728050063,728050064,728050065,728050066,
728050067,728050068,728050069,728050070,728050071,728050072,728050073,728050074,728050075,728050076,
728050077,728050078,728050079,728050080,728050081,728050082,728050083,728050084,728050085,728050086,
728050087,728050088,728050089,728050090,728050091,728050092,728050093,728050094,728050095,728050096,
728050097,728050098,728050099,728050100,728050101,728050102,728050103,728050104,728050105,728050106,
728050107,728050108,728050109,728050110,728050111,728050112,728050113,728050114,728050115,728050116,
728050117,728050118,728050119,728050120,728050121,728050122,728050123,728050124,728050125,728050126,
728050127,728050128,728050129,728050130,728050131,728050132,728050133,728050134,728050135,728050136,
728050137,728050138,728050139,728050140,728050141,728050142,728050143,728050144,728050145,728050146,
728050147,728050148,728050149,728050150,728050151,728050152,728050153,728050154,728050155,728050156,
728050157,728050158,728050159,728050160,728050161,728050162,728050163,728050164,728050165,728050166,
728050167,728050168,728050169,728050170,728050171,728050172,728050173,728050174,728050175,728050176,
728050177,728050178,728050179,728050180,728050181,728050182,728050183,728050184,728050185,728050186,
728050187,728050188,728050189,728050190,728050191,728050192,728050193,728050194,728050195,728050196,
728050197,728050198,728050199,728050200,728050201,728050202,728050203,728050204,728050205,728050206,
728050207,728050208,728060066,728060067,728060068,728060069,728060070,728060071,728060072,728060073,
728060074,728060075,728060076,728060077,728060078,728060079,728060080,728060081,728060082,728060083,
728060084,728060085,728060086,728060087,728060088,728060089,728060090,728060091,728060092,728060093,
728060094,728060095,728060096,728060097,728060098,728060099,728060100,728060101,728060102,728060103,
728060104,728060105,728060106,728060107,728060108,728060109,728060110,728060111,728060112,728060113,
728060114,728060115,728060116,728060117,728060118,728060119,728060120,728060121,728060122,728060123,
728060124,728060125,728060126,728060127,728060128,728060129,728060130,728060131,728060132,728060133,
728060134,728060135,728060136,728060137,728060138,728060139,728060140,728060141,728060142,728070001,
728070002,728070003,728070004,728070005,728070006,728070007,728070008,728070009,728070010,728070011,
728070012,728070013,728070014,728070015,728070016,728070017,728070018,728070019,728070020,728070021,
728070022,728070023,728070024,728070025,728070026,728070027,728070028,728070029,728070030,728070031,
728070032,728070033,728070034,728070035,728070036,728070037,728070038,728070039,728070040,728070041,
728070042,728070064,728070065,728070066,728070067,728070068,728070069,728070070,728070071,728070072,
728070073,728070074,728070075,728070076,728070077,728070078,728070079,728070080,728070081,728070082,
728070083,728070084,728070085,728070086,728070087,728070088,728070089,728070090,728070091,728070092,
728070093,728070094,728070095,728070096,728070097,728070098,728070099,728070100,728070101,728070102,
728070103,728070104,728070105,728070106,728070107,728070108,728070109,728070110,728070111,728070112,
728070113,728070114,728070115,728070116,728070117,728070118,728070119,728070120,728070121,728070122,
728070123,728070124,728070125,728070126,728070127,728070128,728070129,728070130,728070131,728070132,
728070133,728070134,728070135,728070136,728070137,728070138,728070139,728070140,728070141,728070142,
728070143,728070144,728070145,728070146,728070147,728080001,728080002,728080003,728080004,728080005,
728080006,728080007,728080008,728080009,728080010,728080011,728080012,728080014,728080015,728080016,
728080017,728080018,728080019,728080020,728080021,728080022,728080023,728080025,728080026,728080029,
728080030,728080031,728080032,728080034,728080035,728080036,728080037,728080038,728080039,728080040,
728080041,728080042,728080043,728080044,728080045,728080046,728080047,728080048,728080049,728080050,
728080051,728080053,728080054,728080055,728080056,728080057,728080058,728080059,728080060,728080061,
728080062,728080063,728080064,728080066,728080067,728080068,728080069,728080070,728080071,728080072,
728080073,728080074,728080076,728080077,728080078,728080079,728080081,728080083,728080084,728080085,
728080086,728080087,728080088,728080089,728080090,728080091,728080092,728080093,728080094,728080095,
728080096,728080097,728080098,728080099,728080100,728080101,728080102,728080103,728080104,728080105,
728080106,728080107,728080108,728080109,728080110,728080111,728080112,728080113,728080114,728080115,
728080116,728080117,728080118,728080119,728080120,728080121,728080122,728080123,728080124,728080125,
728080126,728080127,728080128,728080129,728080130,728080131,728080132,728080133,728080134,728080135,
728080136,728080137,728080138,728080139,728080140,728080141,728080142,728080144,728080145,728080146,
728080147,728080148,728080149,728080150,728080151,728080152,728080153,728080154,728080155,728080156,
728080157,728080158,728080159,728080160,728080161,728080162,728080163,728080164,728080165,728080166,
728080167,728080168,728080169,728080170,728080171,728080172,728080173,728080174,728080175,728080176,
728080177,728080178,728080179,728080180,728080181,728090056,728090057,728090058,728090059,728090060,
728090061,728090062,728090063,728090064,728090065,728090066,728090067,728090068,728090069,728090070,
728090071,728090072,728090073,728090074,728090075,728090076,728090077,728090078,728090079,728090080,
728090081,728090082,728090083,728090084,728090085,728090086,728090087,728090088,728090089,728090090,
728090091,728090092,728090093,728090094,728090095,728090096,728090097,728090098,728090099,728090100,
728090101,728090102,728090103,728090104,728090105,728090106,728090107,728090108,728090109,728090110,
728090111,728090112,728090113,728090114,728090115,728090116,728090117,728090118,728090119,728090120,
728090121,728090122,728090123,728090124,728090125,728090126,728090127,728090128,728090129,728090130,
728090131,728090132,728090133,728090134,728090135,728090136,728090137,728090138,728090139,728090140,
728090141,728090142,728090143,728090144,728090145,728090146,728090147,728090148,728090149,728090150,
728090151,728090152,728090153,728090154,728090155,728090156,728090157,728090158,728090159,728090160,
728090161,728090163,728090164,728090165,728090166,728090167,728090168,728090169,728090170,728090171,
728090172,728090173,728090174,728090175,728090176,728090177,728090178,728090179,728090180,728090181,
728090183,728090184,728090185,728090186,728090187,728090188,728090189,728090190,728090191,728090192,
728090194,728090195,728090196,728090197,728090198,728090199,728090200,728090201,728090202,728090203,
728090204,728090205,728090206,728090207,728090208,728090209,728090210,728090211,728090212,728090213,
728090214,728090215,728090216,728090217,728090218,728090219,728090220,728090221,728090222,728090223,
728090224,728090225,728090226,728090227,728090228,728090229,728090230,728090231,728090232,728090233,
728090234,728090235,728090236,728090237,728090238,728090239,728090240,728090241,728090242,728090243,
728090244,728090245,728090246,728090247,728090248,728090249,728090250,728090251,728100001,728100002,
728100003,728100004,728100005,728100006,728100007,728100008,728100009,728100010,728100011,728100012,
728100013,728100014,728100015,728100016,728100017,728100018,728100019,728100020,728100021,728100022,
728100023,728100024,728100025,728100026,728100027,728100028,728100029,728100030,728100031,728100032,
728100033,728100034,728100035,728100036,728100037,728100038,728100039,728100040,728100041,728100042,
728100043,728100044,728100045,728100046,728100047,728100048,728100049,728100050,728100051,728100052,
728100053,728100054,728100055,728100056,728100057,728100058,728100059,728100060,728100061,728100062,
728100063,728100064,728100065,728100066,728100067,728100068,728100069,728100070,728100071,728100072,
728100073,728100074,728100075,728100076,728100077,728100078,728100079,728100080,728100081,728100082,
728100083,728100084,728100085,728100086,728100087,728100088,728100089,728100090,728100091,728100092,
728100093,728100094,728100095,728100096,728100097,728100098,728100099,728100100,728100101,728100102,
728100103,728100104,728100105,728100106,728100107,728100108,728100109,728100110,728100112,728100113,
728100114,728100115,728100116,728100117,728100118,728100120,728100121,728100122,728100123,728100124,
728100125,728100126,728100127,728100128,728100129,728100130,728100131,728100132,728100133,728100134,
728100135,728100136,728100137,728100138,728100139,728100140,728100141,728100142,728100143,728100144,
728100145,728100146,728100147,728100148,728100149,728100150,728100151,728100152,728100153,728100154,
728100155,728100156,728100157,728100158,728100159,728100160,728100161,728100162,728100163,728100164,
728100165,728100166,728100167,728100168,728100169,728100170,728100171,728100172,728100173,728100174,
728100175,728100176,728100177,728100178,728100179,728100180,728100181,728100182,728100183,728100184,
728100185,728100186,728100187,728100188,728100189,728100190,728100191,728100192,728100193,728100194,
728100195,728100196,728100197,728100198,728100199,728100200,728100201,728100202,728100203,728100204,
728100205,728100206,728100207,728100208,728100209,728100210,728100211,728110001,728110002,728110003,
728110004,728110005,728110006,728110007,728110008,728110009,728110010,728110011,728110012,728110013,
728110014,728110015,728110016,728110017,728110018,728110019,728110020,728110021,728110022,728110023,
728110024,728110025,728110026,728110027,728110028,728110029,728110030,728110031,728110032,728110033,
728110034,728110035,728110036,728110037,728110038,728110039,728110040,728110041,728110042,728110043,
728110044,728110045,728110046,728110047,728110048,728110049,728110050,728110051,728110052,728110053,
728110054,728110055,728110056,728110057,728110058,728110059,728110060,728110061,728110062,728110063,
728110064,728110065,728110066,728110067,728110068,728110069,728110070,728110071,728110072,728110073,
728110074,728110075,728110076,728110077,728110078,728110079,728110080,728110081,728110082,728110083,
728110084,728110085,728110086,728110087,728110088,728110089,728110090,728110091,728110092,728110093,
728110094,728110095,728110096,728110097,728110098,728110099,728110100,728110101,728110102,728110103,
728110104,728110105,728110106,728110107,728110108,728110109,728110110,728110111,728110112,728110113,
728110114,728110115,728110116,728110117,728110118,728110119,728110120,728110121,728110122,728110123,
728110124,728110125,728110126,728110127,728110128,728110129,728110130,728110131,728110132,728110133,
728110134,728110135,728110136,728110137,728110138,728110139,728110140,728110141,728110142,728110143,
728110144,728110145,728110146,728110147,728110148,728110149,728110150,728110151,728110152,728110153,
728110154,728110155,728110156,728110157,728110158,728110159,728110160,728110161,728110162,728110163,
728110164,728110165,728110166,728110167,728110168,728110169,728110170,728110171,728110172,728110173,
728110174,728110175,728110176,728110177,728110178,728110179,728110180,728110181,728110182,728110183,
728110184,728110185,728110186,728110187,728110188,728110189,728110190,728110191,728110192,728110193,
728110194,728110195,728110196,728110197,728110198,728110199,728110200,728110201,728110202,728110203,
728110204,728110205,728110206,728110207,728110208,728110209,728110210,728110211,728110212,728110213,
728110214,728110215,728110216,728110217,728110218,728110219,728110220,728110221,728110222,728110223,
728110224,728110225,728110226,728110227,728110228,728110229,728110230,728110231,728110232,728110233,
728110234,728110235,728110236,728110237,728110238,728110239,728110240,728110241,728110242,728110243,
728110244,728110245,728110246,728110247,728110248,728110249,728110250,728110251,728110252,728110253,
728110254,728110255,728110256,728110257,728110258,728110259,728110260,728110261,728110262,728110263,
728110264,728110265,728110266,728110267,728110268,728110269,728110270,728110271,728110272,728110273,
728110274,728110275,728110276,728110277,728110278,728110279,728110280,728110281,728110282,728110283,
728110284,728110285,728110286,728110287,728110288,728110289,728110290,728110291,728110292,728110293,
728110294,728110295,728110296,728110297,728110298,728110299,728110300,728110301,728110302,728110303,
728110304,728110305,728110306,728110307,728110308,728110309,728110310,728110311,728110312,728110313,
728110314,728110315,728110316,728110317,728110318,728110319,728110320,728110321,728110322,728110323,
728110324,728110325,728110326,728110327,728110328,728110329,728110330,728110331,728110332,728110333,
728110334,728110335,728110336,728110337,728110338,728110339,728110340,728110341,728110342,728110343,
728110344,728110345,728110346,728110347,728110348,728120001,728120002,728120003,728120004,728120005,
728120006,728120007,728120008,728120009,728120010,728120011,728120012,728120013,728120014,728120015,
728120016,728120017,728120018,728120019,728120020,728120021,728120022,728120023,728120024,728120025,
728120026,728120027,728120028,728120029,728120030,728120031,728120032,728120033,728120034,728120035,
728120036,728120037,728120038,728120039,728120040,728120041,728120042,728120043,728120044,728120045,
728120046,728120047,728120048,728120049,728120050,728120051,728120052,728120053,728120054,728120055,
728120056,728120057,728120058,728120059,728120060,728120061,728120062,728120063,728120064,728120065,
728120066,728120067,728120068,728120069,728120070,728120071,728120072,728120073,728120074,728120075,
728120076,728120077,728120078,728120079,728120080,728120081,728120082,728120083,728120084,728120085,
728120086,728120087,728120088,728120089,728120090,728120091,728120092,728120093,728120094,728120095,
728120096,728120097,728120098,728120099,728120100,728120101,728120102,728120104,728120105,728120107,
728120108,728120109,728120110,728120111,728120112,728120113,728120114,728120115,728120116,728120117,
728120118,728120119,728120120,729010001,729010002,729010003,729010004,729010005,729010006,729010007,
729010009,729010010,729010011,729010012,729010013,729010016,729010017,729010018,729010019,729010020,
729010021,729010022,729010023,729010024,729010025,729010026,729010027,729010028,729010029,729010030,
729010031,729010032,729010033,729010034,729010035,729010036,729010037,729010038,729010039,729010040,
729010041,729010043,729010044,729010045,729010048,729010050,729010051,729010052,729020001,729020002,
729020003,729020004,729020005,729020006,729020008,729020009,729020010,729020011,729020012,729020014,
729020015,729020016,729020017,729020019,729020020,729020021,729020022,729020023,729020024,729020026,
729020027,729020031,729020032,729020033,729020034,729020035,729020036,729020038,729020039,729020040,
729020042,729020044,729020045,729020046,729020047,729020048,729020050,729020051,729020052,729020053,
729020054,729020058,729020059,729020060,729020063,729020068,729020069,729020070,729020071,729020072,
729020073,729020074,729020075,729020076,729020077,729020078,729020079,729020080,729020081,729020083,
729020084,729020085,729020088,729020090,729020091,729020092,729020093,729020095,729020096,729020098,
729020099,729020101,729020103,729020104,729020105,729020108,729020109,729020111,729020114,729020115,
729020117,729020120,729020121,729020123,729020124,729020125,729020127,729020128,729020130,729020131,
729020134,729020135,729020137,729020139,729020140,729020141,729020142,729020143,729020144,729020145,
729020148,729020149,729020150,729020151,729020152,729020154,729020155,729020156,729020157,729020158,
729020159,729020160,729020161,729020162,729020163,729020164,729020165,729020167,729020168,729020169,
729020170,729020174,729020176,729020177,729020178,729020179,729020181,729020185,729020187,729020189,
729020191,729020192,729020193,729020194,729020195,729020196,729020197,729020203,729020204,729020208,
729020210,729020214,729020215,729020222,729020223,729020225,729020226,729020228,729020231
数量　　：1,769台
出荷時期：平成30年3月7日〜平成31年4月9日

製造販売業者の名称　： バクスター株式会社
製造販売業者の所在地： 東京都中央区晴海一丁目８番１０号
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00208
製造業者：Baxter Healthcare Corporation（アメリカ合衆国）
輸入先製造業者：Benchmark Electronics, Inc（アメリカ合衆国）

「ホームPDシステム かぐや」の処方設定において「治療タイプ」を「貯留時間優先」モードで使用した場合、
貯留時間が短くなる恐れがある事を確認いたしました。本不具合は「貯留時間優先」モードで「スマート排液」
が選択された場合のみに発生します。本不具合は「治療時間優先」モードや「タイダール」モードでは発生しま
せん。
注意喚起文書の配布により、製品の有効性及び安全性を維持しながら本不具合の発生を回避する方法の情報提供
を行いました。本情報提供に従った処方設定を行っていただくことにより不具合の発生を回避できます。
しかし、本不具合は製品全体に及ぶ為、改善されたソフトウェアに改修を行います。

「貯留時間優先」モードで「スマート排液」が選択された場合、貯留時間が短くなる恐れがあります。貯留時間
が短縮されることにより、想定以下の除水・溶質除去により不十分な治療に繋がる恐れがあります。
本不具合は、製品の有効性及び安全性を維持しながら発生を回避することが可能ですが、万が一当該回避方法に
従われず本事象が発生した場合も、以下の理由により重篤な健康被害に繋がることはないと考えております。
患者様は十分な教育訓練を受けた後に本製品の使用を開始されます。本事象が発生した場合、「治療結果の差異
(ずれ)」として画面に表示され医療機関に連絡する旨が表示されます。さらに添付文書にも〔治療結果の差異〕
画面が表示された場合、患者様は表示された情報を書き留めて医療機関等に連絡することが指示されており、医
療機関により予防的措置も含めた適切な処置がされます。
なお、現在までに、本事象による健康被害発生の報告はありません。

令和元年5月9日　改修の開始

本品は、自動腹膜灌流に用いる器械であり、透析条件を設定後、専用のディスポーザブルセットと透析液バッグ
チューブを取り付け、自動操作と自動制御により透析液の注液、貯留、排液を繰り返し、腹膜透析を行う装置で
ある。

貸与先医療機関等はすべて把握しており本不具合の発生を回避する方法の情報提供済みです。全ての改修対象製
品のソフトウェアを、改善されたソフトウェアに改修します。

担当者　： 長谷　良隆
連絡先　： バクスター株式会社
　　　　　 信頼性保証本部　品質保証部
電話番号： 03-6204-3840
FAX番号 ： 03-6204-3841