平成24年10月12日作成

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-Eシリーズ
　　　　　　 (2)多人数用透析液供給装置　ACS-Eシリーズ

製造番号：

（対象型式：DAB-10E）
62001-01,62002-01,62002-02,62002-03,62003-01,62003-02,62003-03,62004-01,62004-02,62004-03,
62005-01,62005-02,62005-03,62006-01,62006-02,62006-03,62007-01,62007-02,62007-03,63001-01,
63001-02,63001-03,63002-01,63002-02,63002-03,63003-01,63003-02,63003-03,63004-01,63004-02,
63004-03,63005-01,63005-02,63005-03,63006-01,63006-02,63006-03,64001-01,64001-02,64001-03,
64002-01,64002-02,64002-03,64003-01,64003-02,64003-03,64004-01,64004-02,64004-03,64005-01,
64005-02,64005-03,64006-02,64006-03,64007-01,64007-02,64007-03,65001-01,65001-02,65001-03,
65002-01,65002-02,65002-03,65003-01,65003-02,65003-03,66001-01,66001-02,66001-03,66002-01,
66002-02,66002-03,66003-01,66003-02,66003-03,66004-01,66004-02,66004-03,66005-01,66005-02,
66005-03,67001-01,67002-01,67003-01,67004-01,67005-01,67006-01,67007-01,67008-01,67009-01,
67010-01,67011-01,67012-01,67013-01,67014-01,67015-01,68001-01,68002-01,68003-01,68004-01,
68005-01,68006-01,68007-01,68008-01,68009-01,68010-01,69001-01,69002-01,69003-01,69004-01,
69005-01,69006-01,69007-01,69008-01,69009-01,69010-01,69011-01,70001-01,70002-01,70003-01,
70004-01,70005-01,70006-01,71001-01,71002-01,71003-01,71004-01,71005-01,71006-01,71007-01,
71008-01,72001-01

（対象型式：DAB-20E）
62001-01,62002-01,62003-01,62003-02,62003-03,62004-01,62004-02,62004-03,62005-01,62005-02,
62005-03,62006-01,62006-02,62006-03,62007-01,62007-02,62007-03,62008-01,62008-02,62008-03,
62009-02,62009-03,62010-01,62010-02,62010-03,62011-01,62011-02,62011-03,62012-01,62012-02,
62012-03,62013-01,62013-02,62013-03,62014-01,62014-02,62014-03,62015-02,62015-03,62016-01,
62016-02,62016-03,62017-01,62017-02,62017-03,62018-01,62018-02,62018-03,63001-01,63001-02,
63001-03,63002-01,63002-02,63002-03,63003-01,63003-02,63003-03,63004-01,63004-02,63004-03,
63005-01,63005-02,63005-03,63006-01,63006-02,63006-03,63007-01,63007-02,63007-03,63008-01,
63008-02,63008-03,63009-01,63009-02,63009-03,63010-01,63010-02,63010-03,63011-01,63011-02,
63011-03,63012-01,63012-02,63012-03,63013-01,63013-02,63013-03,63014-02,63014-03,63015-01,
63015-02,63015-03,63016-01,63016-02,63016-03,64001-01,64001-02,64001-03,64002-01,64002-02,
64002-03,64003-01,64003-02,64003-03,64004-01,64004-02,64004-03,64005-01,64005-02,64005-03,
64006-01,64006-02,64006-03,64007-01,64007-02,64007-03,64008-01,64008-02,64008-03,64009-01,
64009-02,64009-03,64010-01,64010-02,64010-03,64011-01,64011-02,64011-03,64012-01,64012-02,
64012-03,64013-01,64013-02,64013-03,64014-01,64014-02,64014-03,64015-01,64015-02,65001-01,
65001-02,65001-03,65002-01,65002-02,65002-03,65003-01,65003-02,65003-03,65004-01,65004-02,
65004-03,65005-01,65005-02,65005-03,65006-01,65006-02,65006-03,65007-01,65007-02,65007-03,
65008-01,65008-02,65008-03,65009-01,65009-02,65009-03,65010-01,65010-02,65010-03,65011-01,
65011-02,65011-03,65012-01,65012-02,65012-03,65013-01,65013-02,65013-03,65014-01,65014-02,
65014-03,65015-01,65015-02,65015-03,66001-01,66001-02,66001-03,66002-01,66002-02,66002-03,
66003-01,66003-02,66003-03,66004-01,66004-02,66004-03,66005-01,66005-02,66005-03,66006-01,
66006-02,66006-03,66007-01,66007-02,66007-03,66008-01,66008-02,66008-03,66009-01,66009-02,
66009-03,66010-01,66010-02,66010-03,66011-01,66011-02,66011-03,66012-01,66012-02,66012-03,
66013-01,66013-02,66013-03,66014-01,66014-02,66014-03,66015-01,66015-02,66015-03,66016-01,
66016-02,66016-03,67001-01,67002-01,67003-01,67004-01,67005-01,67006-01,67007-01,67008-01,
67009-01,67010-01,67011-01,67012-01,67013-01,67014-01,67015-01,67016-01,67017-01,67018-01,
67019-01,67020-01,67021-01,67022-01,67023-01,67024-01,67025-01,67026-01,67027-01,67028-01,
67029-01,67030-01,67031-01,67032-01,67033-01,67034-01,67035-01,67036-01,67037-01,67038-01,
67039-01,67040-01,67041-01,67042-01,67043-01,67044-01,67045-01,67046-01,67047-01,67048-01,
67049-01,67050-01,67051-01,67052-01,67053-01,67054-01,67055-01,67056-01,67057-01,67058-01,
67059-01,67060-01,67061-01,67062-01,67063-01,67064-01,67065-01,67066-01,68001-01,68002-01,
68003-01,68004-01,68005-01,68006-01,68007-01,68008-01,68009-01,68010-01,68011-01,68012-01,
68013-01,68014-01,68015-01,68016-01,68017-01,68018-01,68019-01,68020-01,68021-01,68022-01,
68023-01,68024-01,68025-01,68026-01,68027-01,68028-01,68029-01,68030-01,68031-01,68032-01,
68033-01,68034-01,68035-01,68036-01,68037-01,68038-01,68039-01,68040-01,69001-01,69002-01,
69003-01,69004-01,69005-01,69006-01,69007-01,69008-01,69009-01,69010-01,69011-01,69012-01,
69013-01,69014-01,69015-01,69016-01,69017-01,69018-01,69019-01,69020-01,69021-01,69022-01,
69023-01,69024-01,69025-01,69026-01,69027-01,69028-01,69029-01,69030-01,69031-01,69032-01,
69033-01,69034-01,69035-01,69036-01,69037-01,69038-01,69039-01,69040-01,69041-01,69042-01,
69043-01,69044-01,69045-01,69046-01,69047-01,69048-01,69049-01,69050-01,69051-01,69052-01,
69053-01,69054-01,69055-01,69056-01,70001-01,70002-01,70003-01,70004-01,70005-01,70006-01,
70007-01,70008-01,70009-01,70010-01,70011-01,70012-01,70013-01,70014-01,70015-01,70016-01,
70017-01,70018-01,70019-01,70020-01,70021-01,70022-01,70023-01,70024-01,70025-01,70026-01,
70027-01,70028-01,70029-01,70030-01,70031-01,70032-01,70033-01,70034-01,70035-01,70036-01,
70037-01,70038-01,70039-01,70040-01,70041-01,70042-01,70043-01,70044-01,70045-01,70046-01,
70047-01,70048-01,70049-01,70050-01,70051-01,70052-01,71001-01,71002-01,71003-01,71004-01,
71005-01,71006-01,71007-01,71008-01,71009-01,71010-01,71011-01,71012-01,71013-01,71014-01,
71015-01,71016-01,71017-01,71018-01,71019-01,71020-01,71021-01,71022-01,71023-01,71024-01,
71025-01,71026-01,71027-01,71028-01,71029-01,71030-01,71031-01,71032-01,71033-01,71034-01,
71035-01,71036-01,71037-01,71038-01,71039-01,72002-01

（対象型式：DAB-30E）
62001-01,62001-02,62002-01,62002-02,62002-03,62003-01,62003-02,62003-03,62004-01,62004-02,
62004-03,62005-01,62005-02,62005-03,62006-01,62006-02,62006-03,62007-01,62007-02,62007-03,
62008-02,62008-03,62009-01,62009-02,62009-03,62010-01,62010-02,62010-03,62011-01,62011-02,
62011-03,62012-01,62012-02,62012-03,62013-01,62013-02,62013-03,62014-01,62014-02,62014-03,
62015-01,62015-02,62015-03,62016-01,62016-02,62016-03,62017-02,62017-03,62018-02,62018-03,
62019-01,62019-02,62019-03,63001-03,63002-01,63002-02,63002-03,63003-01,63003-02,63003-03,
63004-01,63004-02,63004-03,63005-01,63005-02,63005-03,63006-01,63006-02,63006-03,63007-01,
63007-02,63007-03,63008-01,63008-02,63008-03,63009-01,63009-02,63009-03,63010-01,63010-02,
63010-03,63011-01,63011-02,63011-03,63012-01,63012-02,63012-03,63013-01,63013-02,63013-03,
63014-01,63014-02,63014-03,63015-01,63015-02,63015-03,63016-01,63016-02,63016-03,63017-01,
63017-02,63017-03,64001-01,64001-02,64001-03,64002-01,64002-02,64002-03,64003-01,64003-02,
64003-03,64004-01,64004-02,64004-03,64005-01,64005-02,64005-03,64006-01,64006-02,64006-03,
64007-01,64007-02,64007-03,64008-03,64009-01,64009-02,64009-03,64010-01,64010-02,64010-03,
64011-01,64011-02,64011-03,64012-01,64012-02,64012-03,64013-01,64013-02,64013-03,64014-01,
64014-02,64014-03,64015-01,64015-02,64015-03,64016-01,64016-02,64016-03,64017-01,64017-02,
64017-03,64018-01,64018-02,64018-03,64019-01,64019-02,64019-03,64020-01,64020-02,64020-03,
64021-01,64021-02,64021-03,64022-01,64022-02,64022-03,64023-01,64023-02,64023-03,65001-01,
65001-02,65001-03,65002-01,65002-02,65002-03,65003-01,65003-02,65003-03,65004-01,65004-02,
65004-03,65005-01,65005-02,65005-03,65006-01,65006-02,65006-03,65007-01,65007-02,65007-03,
65008-01,65008-02,65008-03,65009-01,65009-02,65009-03,65010-01,65010-02,65010-03,65011-01,
65011-02,65011-03,65012-01,65012-02,65012-03,65013-01,65013-02,65013-03,65014-01,65014-02,
65014-03,65015-01,65015-02,65015-03,65016-01,65016-02,65016-03,65017-01,65017-02,65017-03,
65018-01,65018-02,65018-03,65019-01,65019-02,65019-03,65020-01,65020-02,65020-03,65021-01,
65021-02,65021-03,65022-01,65022-02,65022-03,66001-01,66001-02,66001-03,66002-01,66002-02,
66002-03,66003-01,66003-02,66003-03,66004-01,66004-02,66004-03,66005-01,66005-02,66005-03,
66006-01,66006-02,66006-03,66007-01,66007-02,66007-03,66008-01,66008-02,66008-03,66009-01,
66009-02,66009-03,66010-01,66010-02,66010-03,66011-01,66011-02,66011-03,66012-01,66012-02,
66012-03,66013-01,66013-02,66013-03,66014-01,66014-02,66014-03,66015-01,66015-02,66015-03,
66016-01,66016-02,66016-03,66017-01,66017-02,66017-03,67001-01,67002-01,67003-01,67004-01,
67005-01,67006-01,67007-01,67008-01,67009-01,67010-01,67011-01,67012-01,67013-01,67014-01,
67015-01,67016-01,67017-01,67018-01,67019-01,67020-01,67021-01,67022-01,67023-01,67024-01,
67025-01,67026-01,67027-01,67028-01,67029-01,67030-01,67031-01,67032-01,67033-01,67034-01,
67035-01,67036-01,67037-01,67038-01,67039-01,67040-01,67041-01,67042-01,67043-01,67044-01,
67045-01,67046-01,67047-01,67048-01,67049-01,67050-01,67051-01,67052-01,67053-01,67054-01,
67055-01,67056-01,67057-01,68001-01,68002-01,68003-01,68004-01,68005-01,68006-01,68007-01,
68008-01,68009-01,68010-01,68011-01,68012-01,68013-01,68014-01,68015-01,68016-01,68017-01,
68018-01,68019-01,68020-01,68021-01,68022-01,68023-01,68024-01,68025-01,68026-01,68027-01,
68028-01,68029-01,68030-01,68031-01,68032-01,68033-01,68034-01,68035-01,68036-01,68037-01,
68038-01,68039-01,68040-01,68041-01,68042-01,68043-01,69001-01,69002-01,69003-01,69004-01,
69005-01,69006-01,69007-01,69008-01,69009-01,69010-01,69011-01,69012-01,69013-01,69014-01,
69015-01,69016-01,69017-01,69018-01,69019-01,69020-01,69021-01,69022-01,69023-01,69024-01,
69025-01,69026-01,69027-01,69028-01,69029-01,69030-01,69031-01,69032-01,69033-01,69034-01,
69035-01,69036-01,69037-01,69038-01,69039-01,69040-01,69041-01,69042-01,69043-01,69044-01,
69045-01,69046-01,69047-01,69048-01,69049-01,69050-01,69051-01,69052-01,69053-01,70001-01,
70002-01,70003-01,70004-01,70005-01,70006-01,70007-01,70008-01,70009-01,70010-01,70011-01,
70012-01,70013-01,70014-01,70015-01,70016-01,70017-01,70018-01,70019-01,70020-01,70021-01,
70022-01,70023-01,70024-01,70025-01,70026-01,70027-01,70028-01,70029-01,70030-01,70031-01,
70032-01,70033-01,70034-01,70035-01,70036-01,70037-01,70038-01,70039-01,70040-01,70041-01,
70042-01,70043-01,70044-01,70045-01,70046-01,70047-01,70048-01,70049-01,70050-01,70051-01,
71001-01,71002-01,71003-01,71004-01,71005-01,71006-01,71007-01,71008-01,71009-01,71010-01,
71011-01,71012-01,71013-01,71014-01,71015-01,71016-01,71017-01,71018-01,71019-01,71020-01,
71021-01,71022-01,71023-01,71024-01,71025-01,71026-01,71027-01,71028-01,71029-01,71030-01,
71031-01,71032-01,71033-01,71034-01,71035-01,71036-01,71037-01

（対象型式：DAB-40E）
62001-01,62002-01,62002-02,62002-03,62003-01,62003-02,62003-03,62004-01,62004-02,62004-03,
62005-01,62005-02,62005-03,62006-01,62006-02,62006-03,62007-01,62007-02,62007-03,62008-01,
62008-02,62008-03,62009-02,62009-03,62010-01,62010-02,62010-03,62011-01,62011-02,62011-03,
62012-01,62012-02,62012-03,62013-01,62013-02,62013-03,62014-02,62014-03,62015-01,62015-02,
62015-03,62016-01,62016-02,62016-03,63001-01,63001-02,63001-03,63002-01,63002-02,63002-03,
63003-01,63003-02,63003-03,63004-01,63004-02,63004-03,63005-01,63005-02,63005-03,63006-01,
63006-02,63006-03,63007-01,63007-02,63007-03,63008-02,63008-03,63009-01,63009-02,63009-03,
63010-01,63010-02,63010-03,63011-01,63011-02,63011-03,63012-01,63012-02,63012-03,63013-01,
63013-02,63014-01,63014-02,63014-03,63015-01,63015-02,63015-03,63016-01,63016-02,63016-03,
63017-01,63017-02,63017-03,63018-01,63018-02,63018-03,64001-01,64001-02,64001-03,64002-01,
64002-02,64002-03,64003-01,64003-02,64003-03,64004-01,64004-02,64004-03,64005-01,64005-02,
64005-03,64006-01,64006-02,64006-03,64007-01,64007-02,64007-03,64008-01,64008-02,64008-03,
64009-01,64009-02,64009-03,64010-02,64010-03,64011-01,64011-02,64011-03,64012-01,64012-02,
64012-03,64013-01,64013-02,64013-03,64014-01,64014-02,64014-03,64015-01,64015-02,64015-03,
65001-01,65001-02,65001-03,65002-01,65002-02,65002-03,65003-01,65003-02,65003-03,65004-01,
65004-02,65004-03,65005-01,65005-02,65005-03,65006-01,65006-02,65006-03,65007-01,65007-02,
65007-03,65008-01,65008-02,65008-03,65009-01,65009-02,65009-03,65010-01,65010-02,65010-03,
65011-01,65011-02,65011-03,65012-01,65012-02,65012-03,65013-01,65013-02,65013-03,65014-01,
65014-02,65014-03,65015-01,65015-02,65015-03,65016-01,65016-02,65016-03,65017-01,65017-02,
65017-03,65018-01,65018-02,65018-03,65019-01,65019-02,65019-03,65020-01,65020-02,65020-03,
65021-01,65021-02,65021-03,65022-02,65022-03,65023-01,65023-02,65023-03,65024-01,65024-02,
65024-03,66001-01,66001-02,66001-03,66002-01,66002-02,66002-03,66003-01,66003-02,66003-03,
66004-01,66004-02,66004-03,66005-01,66005-02,66005-03,66006-01,66006-02,66006-03,66007-01,
66007-02,66007-03,66008-01,66008-02,66008-03,66009-01,66009-02,66009-03,66010-01,66010-02,
66010-03,66011-01,66011-02,66011-03,66012-01,66012-02,66012-03,66013-01,66013-02,66013-03,
66014-01,66014-02,66014-03,66015-01,66015-02,66015-03,67001-01,67002-01,67003-01,67004-01,
67005-01,67006-01,67007-01,67008-01,67009-01,67010-01,67011-01,67012-01,67013-01,67014-01,
67015-01,67016-01,67017-01,67018-01,67019-01,67020-01,67021-01,67022-01,67023-01,67024-01,
67025-01,67026-01,67027-01,67028-01,67029-01,67030-01,67031-01,67032-01,67033-01,67034-01,
67035-01,67036-01,67037-01,67038-01,67039-01,67040-01,67041-01,67042-01,68001-01,68002-01,
68003-01,68004-01,68005-01,68006-01,68007-01,68008-01,68009-01,68010-01,68011-01,68012-01,
68013-01,68014-01,68015-01,68016-01,68017-01,68018-01,68019-01,68020-01,68021-01,68022-01,
68023-01,68024-01,68025-01,68026-01,68027-01,68028-01,68029-01,68030-01,68031-01,68032-01,
68033-01,68034-01,68035-01,68036-01,68037-01,68038-01,68039-01,68040-01,68041-01,68042-01,
68043-01,68044-01,68045-01,68046-01,69001-01,69002-01,69003-01,69004-01,69005-01,69006-01,
69007-01,69008-01,69009-01,69010-01,69011-01,69012-01,69013-01,69014-01,69015-01,69016-01,
69017-01,69018-01,69019-01,69020-01,69021-01,69022-01,69023-01,69024-01,69025-01,69026-01,
69027-01,69028-01,69029-01,69030-01,69031-01,69032-01,69033-01,69034-01,69035-01,69036-01,
69037-01,69038-01,69039-01,69040-01,69041-01,69042-01,69043-01,69044-01,69045-01,69046-01,
69047-01,69048-01,69049-01,69050-01,69051-01,69052-01,69053-01,69054-01,69055-01,69056-01,
69057-01,69058-01,69059-01,69060-01,69061-01,69062-01,70001-01,70002-01,70003-01,70004-01,
70005-01,70006-01,70007-01,70008-01,70009-01,70010-01,70011-01,70012-01,70013-01,70014-01,
70015-01,70016-01,70017-01,70018-01,70019-01,70020-01,70021-01,70022-01,70023-01,70024-01,
70025-01,70026-01,70027-01,70028-01,70029-01,70030-01,70031-01,70032-01,70033-01,70034-01,
70035-01,70036-01,70037-01,70038-01,70039-01,70040-01,70041-01,70042-01,70043-01,70044-01,
70045-01,70046-01,70047-01,70048-01,70049-01,70050-01,70051-01,70052-01,71001-01,71002-01,
71003-01,71004-01,71005-01,71006-01,71007-01,71008-01,71009-01,71010-01,71011-01,71012-01,
71013-01,71014-01,71015-01,71016-01,71017-01,71018-01,71019-01,71020-01,71021-01,71022-01,
71023-01,71024-01,71025-01,71026-01,71027-01,71028-01,71029-01,71030-01,71031-01,71032-01,
72001-01

（対象型式：DAB-50E）
64001-01,64001-02,64001-03,64002-01,64002-02,64002-03,64003-01,64003-02,64003-03,65001-01,
65001-02,65001-03,65002-01,65002-02,65002-03,65003-01,65003-02,65003-03,65004-01,65004-02,
65004-03,65005-01,65005-02,65005-03,65006-01,65006-02,65006-03,65007-01,65007-02,65007-03,
65008-01,65008-02,65008-03,65009-01,65009-02,65009-03,65010-01,65010-02,65010-03,65011-01,
65011-02,65011-03,65012-01,65012-02,65012-03,65013-01,65013-02,65013-03,65014-01,65014-02,
65014-03,66001-01,66001-02,66001-03,66002-01,66002-02,66002-03,66003-01,66003-02,66003-03,
66004-01,66004-02,66004-03,66005-01,66005-02,66005-03,66006-01,66006-02,66006-03,66007-01,
66007-02,66007-03,66008-01,66008-02,66008-03,66009-01,66009-02,66009-03,66010-01,66010-02,
66010-03,66011-01,66011-02,66011-03,66012-01,66012-02,66012-03,66013-01,66013-02,66013-03,
67001-01,67002-01,67003-01,67004-01,67005-01,67006-01,67007-01,67008-01,67009-01,67010-01,
67011-01,67012-01,67013-01,67014-01,67015-01,67016-01,67017-01,67018-01,67019-01,67020-01,
67021-01,67022-01,67023-01,67024-01,67025-01,67026-01,67027-01,67028-01,67029-01,67030-01,
67031-01,67032-01,67033-01,67034-01,67035-01,67036-01,67037-01,67038-01,67039-01,68001-01,
68002-01,68003-01,68004-01,68005-01,68006-01,68007-01,68008-01,68009-01,68010-01,68011-01,
68012-01,68013-01,68014-01,68015-01,68016-01,68017-01,68018-01,68019-01,68020-01,68021-01,
68022-01,68023-01,68024-01,68025-01,68026-01,68027-01,68028-01,68029-01,68030-01,68031-01,
68032-01,68033-01,68034-01,68035-01,68036-01,68037-01,68038-01,68039-01,68040-01,69001-01,
69002-01,69003-01,69004-01,69005-01,69006-01,69007-01,69008-01,69009-01,69010-01,69011-01,
69012-01,69013-01,69014-01,69015-01,69016-01,69017-01,69018-01,69019-01,69020-01,69021-01,
69022-01,69023-01,69024-01,69025-01,69026-01,69027-01,69028-01,69029-01,69030-01,69031-01,
70001-01,70002-01,70003-01,70004-01,70005-01,70006-01,70007-01,70008-01,70009-01,70010-01,
70011-01,70012-01,70013-01,70014-01,70015-01,70016-01,70017-01,70018-01,70019-01,70020-01,
70021-01,70022-01,70023-01,70024-01,70025-01,70026-01,70027-01,70028-01,70029-01,70030-01,
70031-01,70032-01,70033-01,70034-01,70035-01,70036-01,70037-01,70038-01,70039-01,70040-01,
71001-01,71002-01,71003-01,71004-01,71005-01,71006-01,71007-01,71008-01,71009-01,71010-01,
71011-01,71012-01,71013-01,71014-01,71015-01,71016-01,72001-01

（対象型式：ACS-10E）
64006-01

（対象型式：ACS-20E）
62009-01,62015-01,63014-01,64015-03

（対象型式：ACS-30E）
62008-01,62017-01,62018-01,63001-01,63001-02,64008-01,64008-02

（対象型式：ACS-40E）
62009-01,62014-01,63008-01,63013-03,64010-01,65022-01

数量：1911台

出荷時期：平成14年6月〜平成24年6月

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4丁目20番3号
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00153

製造業者の名称：日機装株式会社
製造業者の所在地：静岡県牧之原市静谷498番地1
薬事の業態：医療機器製造業（一般）
許可番号：22BZ000065

当該装置に接続される透析用監視装置において洗浄・消毒が不足するという事象が発生しました。
調査の結果、当該装置において、自動運転（※）の開始時の工程：「待機」、連動装置電源制御の設定：「制御
する」、接続される透析用監視装置において、自動運転時待機中の電源OFF機能：「電源を切る」、に設定した
場合、当該装置のソフトウエアのバグにより、接続される透析用監視装置の「待機中の電源OFF機能」が翌朝の
洗浄工程まで働いており、透析用監視装置の透析終了後の自動運転において、翌朝の洗浄工程までの「洗浄・消
毒工程」が実施されないことが判明しました。
このため、本事象を回避するための当該装置および透析用監視装置の設定変更の方法に関する情報提供を行うと
ともに、本事象の対策を講じたソフトウエアに修正する改修作業を実施いたします。

※自動運転：透析終了後に当該装置〜透析液供給配管〜接続される透析用監視装置の洗浄・消毒を自動で行う。

本事象が発生する設定を行った場合であっても、通常、設定後の自動運転の動作確認を実施する（透析用監視装
置の装置記録より確認が可能である）ため、自動運転が実施されていないことに気づくと考えております。
しかし、それに気づかずに使用された場合であっても、通常、ダイアライザより下流の配管で認められる付着物
がダイアライザへ逆流することはありません。

従いまして、本事象が患者に重篤な健康被害を及ぼす可能性は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発生の報告は受けておりません。

平成24年10月15日　（情報提供の開始）

本装置は、透析液を所定の比率に希釈・調製して透析用監視装置へ供給する装置であり、医療従事者が使用しま
す。

対象製品の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　： 大原　澄夫
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： 0548-22-5808
FAX番号 ： 0548-22-4577