平成26年 5月13日作成

一般的名称： 補助循環用バルーンポンプ駆動装置
販売名　　： (1)大動脈内バルーンポンプ　システム98
　　　　　　 (2)大動脈内バルーンポンプ　CSシリーズ

販売名：　大動脈内バルーンポンプ　システム98
対象シリアル番号：215台
S803522-B0, S804332-J0, S805166-F1, S805724-K1, S806320-G2, S806505-I2, S806757-L2, S806758-L2,
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S808079-C6, S808148-J6, S808149-J6, S808154-J6, S82496-E9, S82497-E9, S82499-E9

販売名：　大動脈内バルーンポンプ　CSシリーズ
製品番号：CS100
対象シリアル番号：721台
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SA190561D1

販売名：　大動脈内バルーンポンプ　CSシリーズ
製品番号：CS300
対象シリアル番号：354台
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SI143787I8, SI166615J9, SI166745A1, SI166886K9, SI166887K9, SI166892K9, SI166893K9, SI169035L9,
SI169038L9, SI169039L9, SI169040L9, SI169041L9, SI169042L9, SI169043L9, SI169044L9, SI169046L9,
SI169047L9, SI169048L9, SI169049L9, SI169050L9, SI169053L9, SI169054L9, SI169487A0, SI169488A0,
SI169489A0, SI169495A0, SI169496A0, SI169759A0, SI169760A0, SI169763A0, SI169767A0, SI169771A0,
SI169772A0, SI170170A0, SI170171A0, SI170172A0, SI170176A0, SI170178A0, SI170180A0, SI170181A0,
SI170182A0, SI170184A0, SI170191A0, SI170192A0, SI170193A0, SI170465A0, SI170467A0, SI170468A0,
SI170471A0, SI170472A0, SI170473A0, SI170477A0, SI171779B0, SI171788B0, SI171796B0, SI174319D0,
SI176910F0, SI178041F0, SI178042F0, SI178045F0, SI178921G0, SI178926G0, SI178927G0, SI178932G0,
SI178936G0, SI179344G0, SI179348G0, SI179649G0, SI179653G0, SI179660G0, SI179662G0, SI180196H0,
SI180204H0, SI180213H0, SI180214H0, SI181448I0, SI181450I0, SI181451I0, SI181454I0, SI181455I0,
SI181456I0, SI181458I0, SI181460I0, SI181461I0, SI181462I0, SI181465I0, SI182291J0, SI182299J0,
SI182303J0, SI182308J0, SI182311J0, SI182314J0, SI182315J0, SI182316J0, SI182613J0, SI182619J0,
SI182621J0, SI182626J0, SI182630J0, SI182634J0, SI185987L0, SI185988L0, SI185989L0, SI185990L0,
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SI186005L0, SI186006L0, SI186008L0, SI186009L0, SI186740A1, SI186745A1, SI187163A1, SI187170A1,
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SI187482B1, SI187483B1, SI187484B1, SI187485B1, SI187487B1, SI187488B1, SI187490B1, SI187494B1,
SI187789B1, SI187790B1, SI188282B1, SI188283B1, SI188291B1, SI188294B1, SI188296B1, SI188297B1,
SI188300B1, SI188900B1, SI188901B1, SI188904B1, SI188908B1, SI188917B1, SI190066C1, SI190082C1,
SI190086C1, SI190087C1, SI191076D1, SI191079D1, SI191080D1, SI191082D1, SI191087D1, SI191089D1,
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SI192588E1, SI193396F1, SI193398F1, SI193400F1, SI193402F1, SI193403F1, SI193404F1, SI193405F1,
SI193406F1, SI193408F1, SI193410F1, SI193411F1, SI193413F1, SI193417F1, SI193430F1, SI193431F1,
SI196628J1, SI196629J1, SI202193K1, SI202194K1, SI202730K1, SI202735K1, SI202739K1, SI202740K1,
SI202741K1, SI202742K1, SI202745K1, SI202749K1, SI202751K1, SI202753K1, SI203398L1, SI203399L1,
SI214303H3, SI228263E2

出荷数量：1,290台
出荷時期：平成15年1月1日〜平成23年7月15日

製造販売業者の名称　： マッケ・ジャパン株式会社
製造販売業者の所在地： 東京都品川区東品川２‐２‐８　スフィアタワー天王洲
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 13B1X00176
製造業者の名称：データスコープ社
輸入先国：米国

海外製造元データスコープ社は、電源供給ユニットの一部特定の冷却ファンにおいて、その軸受け部分のリテイ
ニングリング（止め輪）が異形になる可能性のあるものが使用されており、冷却ファン内部で当該リテイニング
リングが外れ、ファン回転を停止する原因となる恐れのあることを発見しました。その結果、電源供給ユニット
が過熱状態となり、大動脈内バルーンポンプが視覚的、聴覚的警告無しに緊急停止する可能性のあることを特定
したため、電源供給ユニット内部の冷却ファン交換を行う自主改修に着手することを決定しました。海外製造元
の決定を受けて弊社では、改修対象となる機器の同改修を実施することを決定いたしました。

機器をご使用中、万一当該不具合が発生した場合、ポンプの駆動が停止し、ポンプスクリーンの消灯、ポンピン
グに伴う動作音の消失など、正常な駆動状態とは異なる状況となります。ポンプ駆動が中断することによって、
血行動態の不安定を引き起こす可能性や、IABカテーテルを駆動停止状態で体内に留置したままが継続されます
と血栓形成のリスクが増大します。
尚、IABP施行中は、常に医療関係者の監視下において使用するものであり、ポンプ本体の異常状態が認識された
場合には速やかにポンプの交換、あるいはIABカテーテルの抜去による対応が可能なため、本不具合の状況にお
いても重篤な健康被害が発生する可能性は無いと考えられます。これまで冷却ファンの不具合が原因であると特
定された健康被害発生の報告はありません。

平成26年5月13日

本装置は、心不全時の補助循環に使用される大動脈内バルーンパンピング用の機器です。

当該装置を納入した医療機関は把握しております。この医療機関に対して文書により通知の上、対象製
品を改修します。

担当者　： 杉山　智
連絡先　： マッケ・ジャパン株式会社
　　　　　 品質保証本部　安全管理部
電話番号： 03-5781-3844
FAX番号 ： 03-5463-6857